Meeting Details:

On July 30, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS–100 L/R, sponsored by Glaukos Corp. The device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in subjects with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for phacoemulsification. The patient’s glaucoma should be considered mild to moderate Primary Open Angle Glaucoma, or the secondary open angle glaucomas, Pigmentary Glaucoma and Pseudoexfoliation Glaucoma. Patients with other causes of secondary open angle glaucoma or angle closure glaucomas are not eligible for use of this device. Patients’ IOP should be controlled on 1–3 glaucoma medications and patients should not previously have had surgery for glaucoma.

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug. The input from this public workshop will help in developing topics for further discussion.

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.

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 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 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, 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.

Meeting Details:

On September 14, 2010, 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 July 29, 2010, the committee will discuss Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by FDA to Pfizer, to include assessment of a hemodynamic endpoint. An area of particular interest will be what the appropriate study endpoint should be in patients with PAH unable to perform exercise testing. The discussion will help the agency determine what studies to request for products intended to treat pediatric PAH.

Meeting Details:

On July 28, 2010, the committee will discuss new drug application (NDA) 22433, ticagrelor tablets, 90 milligrams, manufactured by AstraZeneca LP, for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent with blockages in the blood vessels that supply the heart).

Meeting Details:

On July 27, 2010, the committee will discuss, make recommendations and vote on a premarket approval application for the AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP-2 Matrix is used for posterolateral fusion treatment of single level lumbar (L2S1) degenerative disc disease.

Meeting Details:

On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. On July 27, the Committee will discuss blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval.

Meeting Details:

The committees will discuss Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. As a part of the materials for the meeting, FDA anticipates presenting a proposal for a class-wide opioid REMS and will solicit feedback from the advisory committees and public on the components of that proposal. The need for adequate pain control is an element of good medical practice. In this context, some persons suffering from pain need access to potent opioid drug products; however, inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.

Meeting Details:

On July 20, 2010 the committee will discuss supplemental biologics license applications (sBLAs) 125085/191 and 192 for AVASTIN (bevacizumab), manufactured by Genentech, Inc. The two proposed indications (uses) for this product are: (1) first-line treatment of a subgroup of women with metastatic breast cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of chemotherapy drugs, known as taxanes and anthracyclines, or with the chemotherapy drug, capecitabine. In addition to the discussion of these two indications, the committee will also consider the impact of the submitted studies on the conversion from accelerated to regular approval of the indication for the treatment, in combination with the chemotherapy drug paclitaxel, of patients who have not received chemotherapy for their locally recurrent or metastatic HER2 negative breast cancer.

Meeting Details:

On July 15, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22–580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index of 30 kilograms (kg) per square meter, or a body mass index equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities.

Meeting Details:

On both days, the committees will focus primarily on the cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta-analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.