Meeting Details:

The committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae (penicillin susceptible strains).

Meeting Details:

On November 28, 2012, the committee will discuss the safety and effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis.

Meeting Details:

The committee will discuss biologics license application (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc., for the proposed indication of treatment of inhalational anthrax.

Meeting Details:

The committee will discuss new drug application (NDA) 201688, tobramycin inhalation powder, application submitted by Novartis Pharmaceuticals Corporation, and the requested indication of management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.

Meeting Details:

On April 3, 2012, during the morning session, the committee will discuss the development of an animal model of pneumonic plague (plague infection with extensive lung involvement) in African Green Monkeys and provide advice concerning the relevance of the animal model to pneumonic plague in humans resulting from exposure to Yersinia pestis (the bacteria that causes plague) in a bioterrorism event. During the afternoon session, the committee will discuss the data provided to support the safety and efficacy of ciprofloxacin for the treatment of pneumonic plague in humans. The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for ciprofloxacin, based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans. On April 4, 2012, the committee will discuss the data provided to support the safety and efficacy of levofloxacin for the treatment of pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.), has submitted efficacy supplements for LEVAQUIN (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, respectively) for treatment of pneumonic plague. Efficacy data for levofloxacin is based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and postmarketing experience in humans.

Meeting Details:

The committees will provide advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of anthrax exposure. Issues such as the feasibility of an FDAapproved MedKit as a public health strategy, the role of personal MedKits, home stockpiling, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. The Biomedical Advanced Research and Development Authority will propose a possible plan for a step-wise development program for MedKits containing oral doxycycline hyclate.

Meeting Details:

On November 3, the committee will discuss clinical trial design issues for the development of antibacterials for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and the draft document entitled "Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment", published March 2009 (see FDA Web site: Clinical/Antimicrobial Guidances1). On November 4, the committee will discuss clinical trial design issues in the development of antibacterials for the treatment of Hospital-Acquired Bacterial Pneumonia (HABP), including Ventilator-Associated Bacterial Pneumonia (VABP) and the draft document entitled "Guidance for Industry, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment", published November 2010 (see FDA Web site: Clinical/Antimicrobial Guidances1).

Meeting Details:

On April 5, 2011, the committee will discuss new drug application (NDA) 20-1699, for FIDAXOMICIN tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known asClostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.

Meeting Details:

On September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, suOn September 7, 2010, the committee will discuss new drug application (NDA) 200327, for ceftaroline fosamil for injection, submitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.bmitted by Cerexa, Inc., and the requested indications of: (1) Treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.

Meeting Details:

On April 29, 2010, the committee will discuss the efficacy and safety of new drug application (NDA) 21242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available.

Meeting Details:

On December 9, 2009, the committee will discuss endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia. On December 10, the committee will discuss new drug application (NDA) 050-814, inhaled aztreonam, Gilead Sciences, Inc., for the proposed indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection.

Meeting Details:

On October 27, 2009, the committee will discuss Biologic License Application (BLA) 125349, for raxibacumab injection, manufactured by Human Genome Sciences, Inc., proposed for the treatment of inhalational anthrax disease.

Meeting Details:

The committee will discuss updating susceptibility test information in systemic antibacterial drug product labeling.

Meeting Details:

On June 2 - The committee will discuss new drug application (NDA) 22398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia. On June 3 - The committee will discuss issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis. Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of followup) and safety issues.

Meeting Details:

The committee will discuss new drug application (NDA) 22-268, artemether 20 milligrams (mg)/lumefantrine 120 mg, sponsored by Novartis Pharmaceuticals Corp., for the proposed indication of treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum.

Meeting Details:

On November 18, 2008, the committee will discuss the justification of the non-inferiority margin for complicated skin and skin structure infections. On November 19, 2008, the committee will discuss: (1) New drug application (NDA) 022110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection, and (2) NDA 022153, oritavancin, Targanta Therapeutics Corp., proposed for the treatment of complicated skin and skin structure infection. On November 20, 2008, the committee will discuss NDA 022269, iclaprim, Arpida AG, proposed for the treatment of complicated skin and skin structure infection.

Meeting Details:

The committee will discuss new drug application (NDA) 022–171, doripenem powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia.

Meeting Details:

On both days, the committee will discuss product development and clinical trial design for both mild/moderate and moderate/severe community acquired pneumonia (CAP). A primary objective for committee deliberations is to discuss issues relating to the identification of an appropriate noninferiority margin for active controlled trials.

Meeting Details:

On February 27, 2008, the committee will discuss new drug application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. On February 28, 2008, the committee will discuss NDA 022-132, ceftobiprole medocaril (500 milligrams), lyophilized powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of complicated skin and skin structure infection.

Meeting Details:

The committee will discuss clinical trial designs for products that seek indications for the prevention and/or treatment of disease caused by Shiga toxin-producing bacteria. FDA intends to make background material available to the public no later than 1 business day before the meeting.

Meeting Details:

On September 11, 2006, the committee will discuss new drug applications (NDAs) 21-931, garenoxacin mesylate tablets, 400 milligrams (mg) and 600 mg, and NDA 21-932, intravenous garenoxacin mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL of 2 mg/mL), proposed trade name GENINAX, submitted by Schering Corp., for the proposed treatment indications of acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. On September 12, 2006, the committee will discuss supplemental new drug application (sNDA) 21-158/S-006, Factive (gemifloxacin mesylate) Tablets, submitted by Oscient Pharmaceuticals Corp., for the proposed treatment of acute bacterial sinusitis.

Meeting Details:

The committee will discuss new drug application (NDA) 21-572/S-008, Cubicin (daptomycin for injection 500 mg/vial), Sponsor Cubist Pharmaceuticals, for the proposed indication of the treatment of staphylococcus aureus bacteremia, including those with known or suspected endocarditis caused by methicillin-susceptible and methicillin-resistant strains.

Meeting Details:

The subcommittee will meet between 8 a.m. and 1:30 p.m., and the agency will report to the committee on adverse event reporting as mandated in section 17 of the Best Pharmaceuticals for Children Act. The products to be discussed during this portion of the meeting include HYCAMTIN (topotecan), TEMODAR (temozolomide), EFFEXOR (venlafaxine), MONOPRIL (fosinopril), ALLEGRA (fexofenadine), DURAGESIC (fentanyl), CILOXAN (ciprofloxacin), and VIGAMOX (moxifloxacin). Following this, from approximately 1:30 p.m. to 3:30 p.m., the agency will provide an update on neonatal withdrawal syndrome and congenital eye malformations reported in infants whose mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. From approximately 3:30 p.m. to 4 p.m., the agency will provide an overview of the Pediatric Research Equity Act, which was signed into law on December 3, 2003. From 4 p.m. to 4:30 p.m., there will be an overview of the Institute of Medicine report entitled "Ethical Conduct in Pediatric Clinical Trials." Finally, from 4:30 p.m. to 4:45 p.m., the agency will provide an update on the subpart D, institutional review board referral process.

Meeting Details:

On May 10, 2004 the committee will discuss NDA 21-678 (gatifloxacin) for oral suspension Bristol-Myers Squibb’s studied in the treatment of for recurrent bacteria otitis media and treatment failure of acute otitis media in pediatric patients. On May 11, 2004 the committee will discuss the use of microbiologic endpoints as surrogate markers for clinical efficacy in clinical trials designed to demonstrate the safety and efficacy of healthcare anticeptic drug products.

Meeting Details:

On February 3, 2004, the subcommittee will meet between 9 a.m. and 10:15 a.m., and the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA). The products to be reported during this portion of the meeting include: Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine). Following this, from approximately 10:30 a.m. to 4:45 p.m., the subcommittee will discuss the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population. On February 4, 2004, the subcommittee will meet between 8 a.m. and 12 noon to continue the discussion on the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population.

Meeting Details:

The committee will discuss reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder.

Meeting Details:

On October 29th, the committee will discuss the risks of hypothalamic pituitary adrenal axis suppression in children who are being treated a topic dermatitis. The agency will report to the subcommittee on adverse advent reporting as mandadted by the Best Pharmaceuticals for children act. The products to be discuss will be Accupril by Pfizer; Cozaar by Merck; Nolvadex by AstraZeneca, Busulfex Orphan Medical, Serzone by Abbott and Zyrtec by Pfizer. On the 30th, the subcommittew will discuss how to approach long term monitoring for cancer occurence in patients treated for a topic dermatitis or topical immunosuppressants.

Meeting Details:

On October 28, the committee will be closed from 8:00am - noon. From 1:00pm - 5:30pm the committee will discuss clinical trial desgin issues for demonstrating the safety and efficacy of anti-microbials in the treatment of diabetic foot infections. On October 29, the committee will discuss the clinical trial design issues for demonstration the dafety and efficacy of anti-microbials in acute sinusitis.

Meeting Details:

On June 11, 2003, the subcommittee will discuss the current epidemiology and therapeutic interventions relevant to hyperbilirubinemia in the term and near-term newborn. On June 12, 2003, the subcommittee will begin with a closed session between 8 a.m. and 3 p.m. Following this, there will be an open subcommittee meeting from approximately 3:15 p.m. to 5 p.m., where the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act. The products to be discussed during this portion of the meeting include Zoloftâ (sertraline) Pfizer Inc., and Ditropanâ (oxybutynin) Alza Corp., with an interim update to be provided on Lipitorâ (atorvastatin) Pfizer Inc., and Zocorâ (simvastatin) Merck & Co. Inc.

Meeting Details:

On March 4, the committee will discuss NDA 21158 Factive tablets for the treatment of community acquired pneumonia & acute bacteria exasterbastion of chronic bronchitis. On March 5, the committee will discuss the formation of the list of pathogens of public health importance for which Antimicrobial drug development will be desirable. The committee will also discuss the concept of how preclinical data and clinical data from one disease state may support approval of antimicrobial drugs in another state.

Meeting Details:

On March 3, 2003, the subcommittee will discuss the development of antiretroviral drugs in HIV-infected and HIV-exposed neonates younger than four weeks of age. Following this at 2:45 p.m., the agency will provide an update to the subcommittee on the Adverse Event Reporting plan as mandated in Section 17 of the Best Pharmaceuticals for Children Act. After this presentation, at approximately 3:45 p.m., the agency will provide an update on pediatric initiatives within the agency.

Meeting Details:

On January 8, 2003, the committee will discuss new drug application (NDA) 21-144, KETEK (telithromycin), Aventis Pharmaceuticals, Inc., proposed for treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and acute maxillary sinusitis. On January 9, 2003, the committee will discuss issues pertaining to the contents in the document entitled ``Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine (Appendix A of the ``Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern'') (see the FDA Internet site at: http://www.fda.gov/cvm/guidance/dguide152.doc) as it relates to the process for evaluating antimicrobial resistance concerns for the Center for Veterinary Medicine's preapproval safety evaluation of a new animal drug.

Meeting Details:

On July 10, 2002 the committee will discuss NDA 21-242 for artesunate rectocaps for malaria. The meeting will be sponsored by the World Health Organization. On July 11, 2002 the committee will discuss clinical trial design for otitis media.

Meeting Details:

Beginning at 8 a.m., the subcommittee will discuss and receive comments on the ``written request template'' for the proton pump inhibitors in the treatment of gastroesophageal reflux disease in pediatric patients. Starting at 1 p.m., the subcommittee will discuss a ``preliminary priority list'' of drugs for which: (1) Additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population and (2) the drug has no remaining marketing exclusivity or patent protection. This list is mandated by the Best Pharmaceuticals for Children Act and the National Institutes of Health is the designated lead. At 4:30 p.m., representatives from Europe will provide information to the subcommittee on the ongoing pediatric initiatives in the European Union. Following this at 5 p.m., the agency will provide an update to the subcommittee on the pediatric labeling that has resulted from the exclusivity initiative under the FDA Modernization Act and the annual update on the pediatric rule, completed studies, deferrals, and waivers.

Meeting Details:

On February 19, 2002, the committee will hear presentations on the proposed approach for selection of delta in noninferiority (equivalence) clinical trials. The impact of this approach on studies of anti-infective drug products will be considered, with a focus on acute exacerbation of chronic bronchitis and hospital-acquired- pneumonia. On February 20, 2002, the committee will discuss approaches to the development of antimicrobial agents for the treatment of resistant pathogens.

Meeting Details:

The committee will consider the safety and efficacy of a new drug application (NDA) 50-710, Pfizer, Inc., for 1-day and 3-day dosing regimens of azithromycin suspension for the treatment of otitis media.

Meeting Details:

The committee will consider the safety and efficacy of Activated Protein C (human, recombinant, human kidney cells, new biologic license application (BLA) 125029), Eli Lilly & Co. for the treatment of severe sepsis. On 9/13/2001, the Anti-Infective Drugs Advisory Committee will review Bronchitis Trial Design: The committed will focus on trials in acute exacerbation of chronic bronchitis and hospital-acquired pneumonia.

Meeting Details:

The committee will consider the safety and efficiency of the new drug application (NDA) 21-144, Ketek™ (telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis.

Meeting Details:

On April 23, 2001, beginning at 8 a.m., the subcommittee will discuss issues in drug development for pediatric patients with chronic hepatitis C. Beginning at 3:30 p.m., the agency will provide an update to the subcommittee as to recent efforts to ensure adequate labeling and proper pediatric use of therapies. On April 24, 2001, the subcommittee will discuss issues involved in designing clinical trials to study anti-muscarinics for drooling in children with cerebral palsy and other neurologic diseases, as well as the ethical issues involved in performing studies with children having special needs.

Meeting Details:

On January 29, 2001, the committee will consider the safety and efficacy of new drug application (NDA) 21-144, Ketek™ (telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis. On January 30, 2001, the committee will consider the safety and efficacy of new drug application NDA 50-755, Augmentin ES™ (amoxicillin/clavulanate) 90 mg/kg/day, SmithKline Beecham Pharmaceuticals, for the treatment of pediatric patients with acute otitis media due to penicillin resistant Streptococcus pneumoniae.

Meeting Details:

On September 11, 2000, beginning at 8 a.m., the subcommittee will discuss ethical considerations in the conduct of placebo-controlled clinical trials in the pediatric population. Beginning at 3 p.m., the subcommittee will discuss the development of psychotropic drugs for use in young children.

Meeting Details:

The committee will discuss new drug applications (NDA) 21-130, ZyvoxL (linezolid) tablets, NDA 21-131 ZyvoxL for injection (linezolid injection), and NDA 21-132 ZyvoxL Oral Suspension (linezolid oral suspension), Pharmacia & Upjohn Co., for treatment of community-acquired pneumonia, hospital-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and Vancomycin-resistant Enterococcus faecalis and faecium infections, including cases with concurrent bacteremia.

Meeting Details:

On the morning of October 20, the committee will discuss the development of antimicrobial drugs for the treatment of catheter-related bloodstream infections. On the afternoon of October 20, the committee will discuss new drug applications (NDA’s) 20-634 and 20-635, levofloxacin (Levaquin™, The R.W. Johnson Pharmaceutical Research Institute) for the treatment of community acquired pneumonia due to penicillin resistant S.pneumoniae. On October 21, the committee will discuss NDA 21-085, moxifloxacin (Avelox™, Bayer Corporation Pharmaceutical Division), for the treatment of community acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, skin and skin structure infections, and acute sinusitis.

Meeting Details:

The subcommittee will discuss issues in the development and study of all therapies in children relative to the implementation of the agency’s new legislative and regulatory efforts to ensure adequate labeling and proper pediatric use.

Meeting Details:

The committee will discuss new drug application 20-930, pexiganan acetate 1 percent topical cream (Magainin Pharmaceuticals) for treatment of infections in diabetic foot ulcers.

Meeting Details:

The committee will discuss the development of drug products for resistant bacteria, including selective spectrum agents

Meeting Details:

On July 29, 30, and 31, 1998, the Committee will discuss guidance documents for guidance to industry on anti-microbial drug products for the treatment of infections being developed by the Office of Drug Evaluation IV’s Division of AntiInfective Drug Products and Division of Special Pathogens and Immunologic Drug Products.

Meeting Details:

NDAs 50-747 & 50-748 quinupristin/dalfopristin (Synercid(R), Rhone-Poulenc Rorer Pharmaceuticals) for treatment of vancomycin-resistant Enterococcus faecium (VREF) infections, complicated skin and skin structure infections, community-aquired and hospital aquired pneumonias, and for use in the treatment of infections cause by Staphylococcus aureus (including methicillin-susceptible and methicillin-restraint strains).

Meeting Details:

On November 19, 1997, the committee will discuss issues relating to the development of fluoroquinolones for use in pediatric patients. On the morning of November 20, 1997, the committee will discuss new drug application (NDA) 50-585/S046, ceftriaxone sodium (Rocephin sterile vials, Roche Laboratories) for single dose intramuscular treatment of acute otitis media. On the afternoon of November 20, 1997, the committee will discuss NDA 20-799, ofloxacin otic (Floxin, Daiichi Pharmaceuticals) for treatment of otitis externa, chronic suppurative otitis media with perforated tympanic membrane, and acute otitis media in pediatric patients with tympanostomy tubes. On November 21, 1997, the committee will discuss NDA 50-753, tobramycin solution for inhalation (TOBI, PathoGenesis Corp.) for the management of cystic fibrosis patients.

Meeting Details:

On the morning of March 5, 1997, the committee will discuss supplemental new drug application (NDA) 50-679/ S002 Maxipime for Injection (cefepime hydrochloride, Bristol- Myers Squibb), in the treatment of febrile episodes in neutropenic patients. In the afternoon of March 5, 1997, and on March 6 and 7, 1997, the committee will discuss the draft guidance document entitled ``Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products,'' which is currently in the Draft-Not for Implementation stage.

Meeting Details:

Regulation of nonprescription healthcare antiseptic drug products

Meeting Details:

On November 20, 1996, the committees will jointly discuss issues relevant to the use of microbicidal topical vaginal agents against infection with sexually transmitted Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). In light of the significant public health impact of these sexually transmitted diseases, and the difficulties related to the evaluation and promotion of topical vaginal agents as prophylaxis against CT and GC, FDA is soliciting opinions and advice from the advisory committees regarding the development of policy for topical vaginal bacteriocidal agents. Issues for discussion include: (1) The quality and type of data that are available to support the use of such agents as prophylaxis against CT and GC, (2) what additional data would be required by the agency to create a label for such agents, and (3) whom would the appropriate target audience be for such agents. The agency encourages investigators, academicians, and members of the pharmaceutical industry with information about the use of such agents as prophylaxis against infection with CT and GC to respond to this notice. On November 21, 1996, the committees will discuss guidelines for the development of vaginal products for preventing the transmission of the human immunodeficiency virus (HIV). On November 22, 1996, the committees will discuss proposals and guidances for clinical efficacy studies on marketed OTC vaginal spermicides. Issues for discussion will include the type of data and quality of both in vitro and in vivo data needed to support and ensure spermicidal efficacy in final formulation.

Meeting Details:

On July 24, 1996, the committee will discuss issues relevant to: (1) The use of silver sulfadiazine cream 1% in the treatment of patients with chronic wounds; and (2) new drug application (NDA) 19-832, Sulfamylon Solution 5% (mafenide acetate, Mylan Pharmaceuticals, Inc.) for the control of bacterial colonization under moist dressings over meshed autografts on excised burn wounds. On July 25 and 26, 1996, the committee will discuss antibiotic resistance issues. In light of the significant public health impact of increasing bacterial resistance on the future usefulness of antimicrobial agents, FDA is soliciting from the advisory committee opinions and advice regarding the development of policy for antimicrobial drugs intended for the treatment of multidrug resistant (MDR) organisms. Issues for discussion include labeling for the treatment of MDR organism(s), and labeling as second line therapy versus empiric therapy since widespread empiric use may decrease the drug's potential usefulness for treating MDR organisms. The agency encourages investigators, academicians, and members of the pharmaceutical industry with information relevant to the treatment of infections caused by MDR organisms, including current approaches to antimicrobial drug development, to respond to this notice.

Meeting Details:

The committees will meet jointly to discuss data relevant to: (1) Supplemental new drug application (NDA) 50-662/S10 for Biaxin Filmtab (clarithromycin tablets, Abbott Laboratories), clarithromycin in combination with omeprazole for the treatment of active duodenal ulcers and prevention of recurrence of duodenal ulcers associated with Helicobacter pylori; and (2) NDA 20-558 for ranitidine bismuth citrate tablets plus amoxicillin (Tritec, Glaxo Wellcome, Inc.), and NDA 20-559 for ranitidine bismuth citrate tablets plus clarithromycin (Tritec, Glaxo Wellcome, Inc.), for healing and prevention of duodenal ulcer relapse due to H. pylori infection when used in conjunction with clarithromycin or amoxicillin.

Meeting Details:

The committee will discuss the diagnosis of Helicobacter pylori related gastrointestinal disease and resistance implications of widespread Helicobacter pylori treatment.

Meeting Details:

The committees will meet jointly to discuss treatment of Helicobacter pylori to reduce peptic ulcer recurrence and to discuss resistance implications of widespread Helicobacter pylori treatment.

Meeting Details:

The committee will discuss the validity of endoscopically-obtained maxillary sinus specimens versus antral puncture for the microbiological diagnosis of sinusitis. FDA public advisory committee meetings may have as many as four separable portions: (1) An open public hearing, (2) an open committee discussion, (3) a closed presentation of data, and (4) a closed committee deliberation.

Meeting Details:

The committee will discuss surrogate markers, such as pharmacokinetic parameters and microbiological inhibitory and cidal data, and whether these parameters can be used instead of clinical efficacy data to support an alternative dosing regimen for oral metronidazole in the treatment of Trichomonas vaginalis vaginitis.

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of LOTRONEX (alosetron hydrochloride) tablets, by Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Meeting Details:

On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium.

Meeting Details:

Day 1: The committee will discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. On July 23, 2013, during the morning session, the committee will discuss supplemental biologics license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc., for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein or magnetic resonance imaging, who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. During the afternoon session, the committee will discuss sBLA 125160, certolizumab injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Meeting Details:

On August 5, 2013, the committee will discuss new drug application (NDA) 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure).

Meeting Details:

On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Meeting Details:

On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.