Meeting Details:

The committee will discuss new drug application (NDA) 203-100, for a fixeddose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components.

Meeting Details:

The committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Meeting Details:

On December 14 and 15, 2011, the committee will discuss pathways for the development of drugs intended to treat variola virus infection (smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.

Meeting Details:

On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function. On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

Meeting Details:

On June 2, 2010, the committee will discuss biologics license application (BLA) 125283, motavizumab, MedImmune, LLC, proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Meeting Details:

The committee will discuss an efficacy supplement for new drug application (NDA) 022-128, maraviroc 300 milligram tablets, Pfizer, Inc., proposing a new indication for the treatment of antiretroviral-naive patients with chemokine (c-c motif) receptor 5 (CCR5--tropic human immunodeficiency virus (HIV).

Meeting Details:

On December 2, 2008, the committee will begin with a closed session from 8 a.m. to 10:30 a.m., to permit discussion and review of trade secret and/or confidential information. Following the closed session, from 10:30 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of new drug application (NDA) 20-725, Creon (pancrelipase delayed-release capsules), Solvay Pharmaceuticals, Inc., for the treatment of exocrine pancreatic insufficiency.

Meeting Details:

The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions.

Meeting Details:

On September 5, 2007, the committee will discuss new drug application (NDA) 22–145, raltegravir potassium, integrase inhibitor 400 milligram tablets, Merck & Co., Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV–1) infection in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV–1 replication despite ongoing antiretroviral therapy.

Meeting Details:

The committee will discuss new drug application (NDA) 022- 128, maraviroc 300 milligram tablets, Pfizer, Inc., proposed for the treatment of antiretroviral-experienced patients with chemokine (c-c motif) receptor 5 (CCR5)--tropic human immunodeficiency virus (HIV).

Meeting Details:

On both days, the committee will discuss clinical trial design issues in the development of products for treatment of chronic hepatitis C infection. This meeting is being convened in response to the growing number of products in development for this indication. The primary objectives for committee deliberations are to discuss issues relating to the identification of appropriate control arms, populations for study, endpoints, and long-term followup. On October 20, 2006, the meeting will be open to the public from 8 a.m. to 12 noon, unless public participation does not last that long; from 1 p.m. to 4 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information.

Meeting Details:

The committee will discuss new drug application (NDA) 21-814, proposed trade name APTIVUS (Tipranavir) 250 milligram capsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for the treatment of patients with human immunodeficiency virus HIV.

Meeting Details:

On march 11, 2005, The FDA committee will discuss NDA 21-797 and NDA 21-798 entecavir tablets and oral solution by Bristol-Myers Squibb’s proposed treatment for patients with chronic hepatitis B infection (HBV). Source: FDA AdComm Hotline

Meeting Details:

The committee will discuss the following topics: (1) Issues related to clinical trial design and analysis in studying catheter-related bacteremia and (2) issues related to clinical trial design and analysis in studying bacteremia due to staphylococcus aureus.

Meeting Details:

On August 20, the committee will discuss clinical trial design issues in the development of topical microbicide for the reduction of HIV transmission.

Meeting Details:

On May 13, 2003, the committee will discuss new drug applications (nDA) 21-567 and 21-568, Reyataz (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents. On May 14, 2003, the committee will discuss supplemental new drug application (sNDA) 20-550/S-019, Valtrex (valacyclovir hydrochloride) caplets, GlaxoSmithKline, proposed for reduction of the risk of transmission of genital herpes with the use of suppressive therapy.

Meeting Details:

On Nov 14, The committee will discuss Peg Interferon / co-packaged with Ribavirin sponsored by Hoffman La-Roche Inc. purposed as combination therapy for the treatment of chronic hepatitis C.

Meeting Details:

On August 6th, the committee will discuss NDA21449 Adefovir Dipivoxil tablets sponsored by Gilead Sciences Inc. proposed for treatment of chronic hepatitis B infection. On August 7th, the committee will discuss clinical trial design issues in development of products for treatment of hepatits B infection.

Meeting Details:

The committee will discuss new drug application (NDA) 21- 245, Picovir (pleconaril), ViroPharma Inc., proposed for treatment of acute viral respiratory infection (the common cold) in adults.

Meeting Details:

The subcommittee will discuss new drug applications (NDAs)21-083/SE1-006 and 21-110/SE1-004, RAPAMUNE (sirolimus) oral solution and tablets, Wyeth-Ayerst Research, approved for prophylaxis of organ rejection in patients receiving renal transplants. As stated in the approved labeling, it is recommended that RAPAMUNE be used in a regimen with cyclosporine and corticosteroids. The discussion is for the proposed elimination of cyclosporine from the immunosuppressive regimen 2 to 4 months after transplantation under certain conditions.

Meeting Details:

The committee will be updated on the approval of biologics license application supplement (BLs) 103949/5002, PEG-Intron™, (peginterferon alpa-2b) Powder for Injection, Schering Corporation, indicated for use alone or in combination with Rebetol (ribavirin, USP), for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.

Meeting Details:

On October 3, 2001, the committee will discuss new drug application (NDA) 21-356, VireadTM (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., proposed for the treatment of human immunodeficiency virus (HIV) infection. On October 4, 2001, the committee will discuss NDA 21-266, VfendTM (voriconazole) Tablets and NDA 21-267, VfendTM I.V. (voriconazole) for infusion, Pfizer Global Research and Development, proposed for the treatment of invasive aspergillosis, serious Candida infections, infections caused by Scedosporium spp. and Fusarium spp., rare and refractory infections, and empirical treatment of febrile neutropenia.

Meeting Details:

The committee will discuss new drug application (NDA) 21-304, valganciclovir hydrochloride tablets, 450mg, Syntex (U.S.A.) LLC, proposed for treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Meeting Details:

---- DAY 1 ----The committee will discuss new drug application (NDA) 21-227, Cancidas™ (caspofungin) Injection, Merck Research Laboratories, indicated for treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. ---- DAY 2 ---- Presentations and committee discussions will focus on clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options (treatment sometimes referred to as "salvage" therapy). This meeting is being convened in response to the recognized difficulty in evaluating the safety and effectiveness of new antiretroviral therapeutics in heavily pretreated patients. A further goal of this meeting is to facilitate and promote the development of new therapies for patients who are most in need of new therapeutic options. For the purpose of this meeting, we will define "salvage" therapy as regimens that follow a loss or lack of virologic response to at least two previous antiretroviral regimens that, in total, have consisted of drugs from all of the approved drug classes (protease inhibitors, nucleoside and non-nucleoside reverse transcriptase inhibitors). This population of heavily pretreated patients reflects a population for whom selection of active controls in clinical trials is a particular challenge.

Meeting Details:

The committee will discuss the use of surrogate markers in the early development of immunomodulatory agents for the treatment of patients with human immunodeficiency virus (HIV).

Meeting Details:

On July 25, 2000, the committee will discuss scientific data characterizing relationships of pharmacokinetic parameters and virologic response to approved antiretroviral drugs used in the treatment of human immunodeficiency virus (HIV) infection. The primary objectives for the committee deliberations are to explore the use of pharmacokinetic data to improve the evaluation of new formulations, alternative dosing regimens, and choice of dosing in the setting of drug-drug interactions for approved antiretroviral drugs. Additionally, other issues to be discussed include: the relationship between pharmacokinetic parameters and drug toxicity, and safety requirements and pediatric considerations for alternative dosing regimens.

Meeting Details:

On the 1st of November, the committee will discuss adefovir dipivoxil (Gilead Sciences Inc.), for the treatment of human immunodeficiency virus infection. On the 2nd & 3rd of November, They will discuss issues related to testing for development of resistant human immunodeficiency virus (HIV-1), with an emphasis on its potential role in antiretroviral drug development. The primary objectives of these deliberations are to obtain advisory committee recommendations on the amount and type of resistance data needed to support both preclinical and clinical development of antiretroviral drugs & product labeling.

Meeting Details:

On October 4, 1999, presentations and committee discussions will address issues related to the potential applicability of information from non-U.S. studies of prevention of perinatal human immunodeficiency virus transmission to U.S. clinical settings.

Meeting Details:

The subcommittee will discuss the new drug application (NDA) 21-083, Rapamune (sirolimus, Wyeth-Ayerst Laboratories) for the prophylaxis of organ rejection in patients receiving renal transplants. *** Call for Satellite, Videoconferencing and Webcasting ***

Meeting Details:

The committee will discuss new drug application (NDA) 21- 036, zanamivir for inhalation (Relenza, Glaxo Wellcome, Inc.), for the treatment of influenza A and B.

Meeting Details:

The committee will discuss new drug applications (NDA) 20-977 (tablets) and 20-978 (oral solution) for abacavir sulfate (Ziagen, Glaxo Wellcome, Incorporated) for the treatment of human immunodeficiency virus (HIV) infection

Meeting Details:

The committee will discuss new drug applications (NDA) N21-003 (100-milligram (mg) tablets) and NDA N21-004 (5 mg/milliliter oral solution) for lamivudine (Epivir HBV, Glaxo Wellcome, Inc.) for the treatment of chronic hepatitis B.

Meeting Details:

On the morning of July 14, 1998, the committee will hear presentations on general regulatory procedures and policies including: the use of HIV RNA as an endpoint for accelerated and traditional approvals, FDA’s initiatives to encourage pediatric drug development, implications of the FDA modernization act (FDAMA) for the regulation of antiviral drug products, and the current mechanisms for post-marketing surveillance. Antiretroviral class adverse events, including those observed with HIV protease inhibitors, will be presented to illustrate post-marketing surveillance procedures.

Meeting Details:

On May 4, 1998, the committee will discuss New Drug Application (NDA) 20-903, Intron®A/Rebetol (interferon alfa-2b, recombinant/ribavirin, Schering Corporation) for the treatment of chronic hepatitis C. On May 5, 1998, the committee will discuss NDA 50-752, Priftin® (rifapentine, Hoechst Marion Roussel, Inc.) for the treatment of pulmonary tuberculosis. On May 6, 1998, the committee will discuss NDA 20-871, NTZTM (nitazoxanide, UNIMED Pharmaceuticals, Inc.)for the treatment of diarrhea associated with cryptosporidiosis in AIDS patients.

Meeting Details:

On July 14 and 15, 1997, the committee will discuss the utility of plasma human immunodeficiency virus (HIV) RNA measurement as an endpoint in clinical trials for drugs to treat HIV infection. In light of the rapid changes in knowledge about the pathophysiology of HIV infection, the advances in the technologies to quantify HIV in plasma, and the evolution of antiviral therapy, FDA is soliciting opinions and advice from the advisory committee on this topic. On July 16, 1997, the committee will discuss data relevant to new drug application (NDA) 50-740, AmBisome (liposomal amphotericin B, Fujisawa, USA), as empirical therapy for presumed fungal infection in febrile neutropenic patients.

Meeting Details:

The committee will discuss data relevant to a supplemental new drug application for the approved drug, Amphotec TM, (amphotericin B cholesteryl sulfate complex, Sequus Pharmaceuticals, Inc.), for use in the empiric therapy of febrile neutropenic patients.

Meeting Details:

The committee will discuss data relevant to new drug application (NDA) 20-705, Rescriptor, (delavirdine, Pharmacia and Upjohn Co.) for use in the treatment of HIV infection.

Meeting Details:

On June 6, 1996, the committee will discuss data relevant to new drug application (NDA) 20-585, Bravavir (sorivudine), Bristol Myers Squibb, for use in the treatment of herpes zoster in immunocompromised adults. On June 7, 1996, the committee will discuss data relevant to NDA 20-636, Viramune (nevirapine), Boehringer Ingelheim, for use in the treatment of human immunodeficiency virus infection.

Meeting Details:

On March 15, 1996, the Antiviral Drugs Advisory Committee and an ophthalmic drugs subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee will meet jointly to discuss data relevant to NDA 20-638 Vistide TM (cidofovir, intravenous, Gilead Sciences, Inc.) for treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.

Meeting Details:

On February 28, 1996, the committee will discuss recent studies with nucleoside analogues for the treatment of human immunodeficiency virus (HIV) infection. The discussion will include data from AIDS Clinical Trial Group (ACTG) Study 175, the Delta studies, and other relevant studies. Data pertinent to the following NDA's will be included in the discussion: Bristol Myers Squibb NDA's 20-154, 20-155, and 20-156 for Videx (didanosine) chewable tablets, buffered powder for oral solution, and pediatric powder for oral solution; Glaxo Wellcome NDA's 19-665 and 19-910 for Retrovir (zidovudine) capsules and syrup; Roche Laboratories' NDA 20-199 for HIVID (zalcitabine) tablets. On February 29, 1996, the committee will discuss data relevant to NDA's 20-659 and 20- 680 ritonavir (liquid and capsules, Abbott Laboratories) for treatment of HIV infection. On March 1, 1996, the committee will discuss data relevant to NDA 20-685 Crixivan TM (indinavir capsules, Merck and Co., Inc.) for treatment of HIV infection.

Meeting Details:

On November 6, 1995, the committee will discuss data relevant to new drug applications (NDA's) 20-564 (tablets) and 20-596 (oral solution) for lamivudine (Epivir TM, also known as 3TC), sponsored by Glaxo Wellcome. On November 7, 1995, the committee will discuss data relevant to NDA 20-628 for saquinavir (Invirase TM), sponsored by Hoffman-La Roche. On November 8, 1995, the committee will discuss confirmatory trials of stavudine (Zerit TM, also known as d4T), sponsored by Bristol-Myers Squibb. All products listed above are for the treatment of human immunodeficiency virus infection.

Meeting Details:

The National Task Force on AIDS Drug Development shall identify any barriers and provide creative options for the rapid development and evaluation of treatments for human immunodeficiency virus (HIV) infection and its sequelae. It also advises on issues related to such barriers, and provides options for the elimination of these barriers. The Antiviral Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC), and other viral, fungal, and mycobacterial infections.

Meeting Details:

During the morning of July 20, 1995, the committee will discuss treatment goals of the short-term therapy of cystitis, including safety and efficacy data for the fosfomycin tromethamine NDA 50-717, Forest Laboratories, Inc./Zambon Corp. During the afternoon, the committee will revisit the FDA/Infectious Diseases Society of America guidelines for evaluating new treatment regimens for urinary tract infections.

Meeting Details:

The committee will hear presentations and discuss scientific issues relevant to liposomal antifungal agents.

Meeting Details:

The committee will discuss Zovirax Rx to over-the-counter Switch.

Meeting Details:

On November 17, 1994, the committee will discuss data relevant to NDA 20-460 for oral ganciclovir (Cytovene, Syntex Laboratories, Inc.) for the treatment of cytomegalovirus retinitis in immunocompromised patients, where the retinitis is stable after prior therapy. On November 18, 1994, the committee will hear scientific presentations on aspects of clinical trial design for drugs used for hepatitis. Closed committee deliberations. On November 18, 1994, the committee will discuss trade secret and/or confidential commercial information relevant to pending NDA's.

Meeting Details:

The committee will jointly discuss the potential for development of antibiotic resistance with over-the- counter use of topical erythromycin in the treatment of acne.

Meeting Details:

The committee will discuss scientific and medical issues relevant to the validation of surrogate markers for use as criteria in regulatory decisionmaking.

Meeting Details:

The committee will discuss data submitted in support of supplementary new drug applications (NDA's) 19- 655 (supplement 023), 19-910 (supplement 011), and 19-951 (supplement 003) for zidovudine (Retrovir, Burroughs Welcome) for use as prophylaxis against maternal to fetal transmission of HIV infection.

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.