Meeting Details:

The committee will discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML. During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.

Meeting Details:

The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S–013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).

Meeting Details:

On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA- 2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient t

Meeting Details:

The workshop will include plenaries and breakout sessions on the ethical and regulatory challenges in the development of medical countermeasures for the pediatric population. Topics of the breakout sessions will include: (1) Institutional Review Board preparedness to review study protocols relevant to pediatric medical countermeasures; (2) potential scientific and ethical justifications for conducting pre-event pediatric medical countermeasures research; (3) leveraging new technologies to develop pediatric medical countermeasures; and (4) risk communication related to pediatric treatment and research during public health emergencies. The workshop also will include discussion of a number of case studies to facilitate discussion of the challenges of pediatric medical countermeasure development and deployment.

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) 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 comorbidities.

Meeting Details:

The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non- Diabetic Autonomic Neuropathy.

Meeting Details:

The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Meeting Details:

The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): 1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of 3 ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA's Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.

Meeting Details:

On February 29, 2012, the committee will discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear the following updates: Report from the Health and Human Services Advisory Committee on Blood Safety and Availability and summary of the December 5-6, 2011, meeting; update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; summary of the November 8-9, 2011, public workshop on hemoglobin standard and maintaining an adequate blood supply; summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products; and an update on thrombotic adverse events and immune globulin products.

Meeting Details:

The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

Meeting Details:

The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.

Meeting Details:

On March 20, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 022465/S-010, VOTRIENT (pazopanib hydrochloride) Tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd. doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors. During the afternoon session, the committee will discuss NDA 022576, with the proposed trade name TALTORVIC (ridaforolimus) Tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.

Meeting Details:

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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel—releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).

Meeting Details:

The committee will discuss the benefits and risks of new drug application 22- 139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of "reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.” The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the U.S. population.

Meeting Details:

On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.