Pediatric Advisory Committee
December 7, 2010, from 8 a.m. to 6 p.m.
Agenda: The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Prevista (darunavir ethanolate), PegIntron (peginterferon alfa-2b), Xyzal(levocetirizine dihydrochloride) tablet and solution, Flovent HFA (fluticasone propionate), Acanya Gel (clindamycin/benzoyl peroxide combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). The committee will also receive a followup on Depakote ER (divalproex sodium). Committee members who participated in the Cardiovascular and Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee meetings held on July 29, 2010, and November 5, 2010, respectively, will provide a brief summary of the meetings.
Friday, November 12, 2010
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
December 7, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 7, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE (naltrexone HCl/bupropion HCl)extended release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial 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 with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). 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.
December 7, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 7, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE (naltrexone HCl/bupropion HCl)extended release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial 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 with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). 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.
Pediatric Advisory Committee
Pediatric Advisory Committee
December 6, 2010, from 8 a.m. to 6 p.m.
Agenda: The Pediatric Advisory Committee (PAC) will meet to discuss donor and banked human milk. FDA is convening the meeting to obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking of human milk.
December 6, 2010, from 8 a.m. to 6 p.m.
Agenda: The Pediatric Advisory Committee (PAC) will meet to discuss donor and banked human milk. FDA is convening the meeting to obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking of human milk.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
December 3 from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions.
December 3 from 8 a.m. to 6 p.m. (Day 2 of 2)
Agenda: On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Meeting on December 2 from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy.
Meeting on December 2 from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy.
Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
December 2, 2010, from 8 a.m. to 4:30 p.m.
Agenda: On December 2, 2010, the committees will begin with a closed session from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. The committees will discuss new drug application (NDA) 201655, Oxymorphone HCl Extended-Release Tablets, Endo Pharmaceuticals, Inc., and its safety for the proposed indication of relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time. The extended-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxymorphone.
December 2, 2010, from 8 a.m. to 4:30 p.m.
Agenda: On December 2, 2010, the committees will begin with a closed session from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. The committees will discuss new drug application (NDA) 201655, Oxymorphone HCl Extended-Release Tablets, Endo Pharmaceuticals, Inc., and its safety for the proposed indication of relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time. The extended-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxymorphone.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
December 2, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 2, 2010, during the morning session, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee will discuss new drug application (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer.
December 2, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 2, 2010, during the morning session, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee will discuss new drug application (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
December 1, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules,manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride)Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposedexpansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined.
December 1, 2010, from 8 a.m. to 5 p.m.
Agenda: On December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules,manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride)Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposedexpansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
November 30, 2010, from 8 a.m. to 5:30 p.m.
Agenda: On November 30, 2010, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA or, are in late stage development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc.
November 30, 2010, from 8 a.m. to 5:30 p.m.
Agenda: On November 30, 2010, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA or, are in late stage development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc.
Cellular, Tissue and Gene Therapies Advisory Committee
Cellular, Tissue and Gene Therapies Advisory Committee
November 19, 2010, from 8:30 a.m. to 5 p.m.
Agenda: On November 19, 2010, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.
November 19, 2010, from 8:30 a.m. to 5 p.m.
Agenda: On November 19, 2010, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
November 18, 2010, from 1 p.m. until 5 p.m.
Agenda: On November 18, 2010, the committee will (1) Receive an update on the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.
November 18, 2010, from 1 p.m. until 5 p.m.
Agenda: On November 18, 2010, the committee will (1) Receive an update on the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
November 18, 2010, from 8:00 a.m. to 6:00 p.m
MelaFind -sponsored by MELA Sciences, Inc.
Agenda: On November 18, 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.
November 18, 2010, from 8:00 a.m. to 6:00 p.m
MelaFind -sponsored by MELA Sciences, Inc.
Agenda: On November 18, 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.
On Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer,
On Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
Committee Meeting on November 17, 2010 8:00 a.m. TO 5:00 p.m
Provenge - Sponsored by Denedron
Agenda: The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer. As described on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm213559.htm, PROVENGE (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF). FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T. Provenge has FDA approved labeling for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Committee Meeting on November 17, 2010 8:00 a.m. TO 5:00 p.m
Provenge - Sponsored by Denedron
Agenda: The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer. As described on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm213559.htm, PROVENGE (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF). FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T. Provenge has FDA approved labeling for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Vaccines and Related Biological Products Advisory Committee,
Vaccines and Related Biological Products Advisory Committee
November 17, 2010, from 8:30 a.m. to 1:15 p.m. (Day 2 of 2)
Gardasil manufactured by Merck & Co.
Agenda: On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer.
November 17, 2010, from 8:30 a.m. to 1:15 p.m. (Day 2 of 2)
Gardasil manufactured by Merck & Co.
Agenda: On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer.
Vaccines and Related Biological Products Advisory Committee,
Vaccines and Related Biological Products Advisory Committee,
November 16, 2010, from 9 a.m. to 4 p.m. (Day 1 of 2)
Agenda: On November 16, 2010, the committee will meet in open session to review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule.
November 16, 2010, from 9 a.m. to 4 p.m. (Day 1 of 2)
Agenda: On November 16, 2010, the committee will meet in open session to review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule.
Arthritis Advisory Committee
Arthritis Advisory Committee
November 16th 2010, , from 8:00 a.m. to 5:00 p.m
belimumab, proposed trade name BENLYSTA - Sponsored by Human Genome Sciences
Agenda: On November 16, 2010, the committee will discuss biologic license application 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus
November 16th 2010, , from 8:00 a.m. to 5:00 p.m
belimumab, proposed trade name BENLYSTA - Sponsored by Human Genome Sciences
Agenda: On November 16, 2010, the committee will discuss biologic license application 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus
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