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:

The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.

Meeting Details:

On September 15, 2010, the committee will discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01392), for new drug application (NDA) 20632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for treatment of obesity. The SCOUT study was a randomized, double-blind, placebo-controlled trial, which is a kind of clinical trial designed to provide data with strong measures of accuracy and reliability. The SCOUT trial evaluated the potential benefits of weight loss with MERIDIA on major cardiovascular (heart and blood circulation) adverse events. The preliminary results of the SCOUT trial indicated that clinical trial participants who received MERIDIA instead of placebo (no active drug) had a higher incidence of major cardiovascular adverse events that was statistically significant. On September 16, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22529, with the proposed trade name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities (which include, for example: High blood pressure, heart disease, or diabetes). The BMI is a measure of body weight (mass) based on a person's weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

Meeting Details:

The committee will discuss the available safety and efficacy data for supplemental new drug application (sNDA) 21897/015, VIVITROL (naltrexone for extended-release injectable suspension), sponsored by Alkermes, Inc., for the treatment of opioid dependence.

Meeting Details:

The committee will discuss new drug application (NDA) 22512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

Meeting Details:

On August 26, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

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 August 20, 2010, the committees will discuss new drug application (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older . The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed.

Meeting Details:

On August 19, 2010, the committee will discuss the available safety and efficacy data for new drug application (NDA) 22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as it relates to the proposed indication of treatment of chronic pain.

Meeting Details:

On August 11, 2010, the committee will discuss new drug application (NDA) 22-345, with the proposed trade name POTIGA (ezogabine) Tablets, by Valeant Pharmaceuticals North America. The proposed indication for this new drug product is adjunctive therapy in patients with partial-onset seizures.