JUL 13 AAC

July 11, 2016 jessica adams

Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis

JUL 12 AAC

July 8, 2016 jessica adams

Desmopressin nasal spray by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia

JUN 28-29 ODAC

June 27, 2016 jessica adams

PWRs for (1) VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT, application sponsored by Epizyme, Inc.; (3) ATEZOLIZUMAB, application sponsored by Roche/Genentech; (4) LOXO-101, application sponsored by Loxo Oncology, Inc.; and (5) ENTRECTINIB, application sponsored by Ignyta, Inc. Also, treatment appproaches for diffuse intrinsic pontine glioma (DIPG).

JUN 28 EMDAC

June 24, 2016 jessica adams

Boehringer Ingelheim Pharmaceuticals and Eli Lilly's JARDIANCE and SYNJARDY proposed new indication to reduce CV risk

JUN 23 PCAC

June 21, 2016 jessica adams

Review of 6 substances nominated for inclusion on the section 503A bulk drug substances list. Updates on discussions from previous meetings, including the option for expanded access.

JUN 20 BPAC

June 15, 2016 jessica adams

Research programs in CBER's Laboratory of Plasma Derivatives

JUN 9 AMDAC

June 7, 2016 jessica adams

Merck's bezlotoxumab for the prevention of Clostridium difficile (C. diff) infection recurrence

JUN 8 AADPAC-DSRM

June 6, 2016 jessica adams

Pfizer's oxycodone/naltrexone extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties.

JUN 7 AADPAC-DSRM

June 6, 2016 jessica adams

Teva's hydrocodone bitartrate extended-release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

MAY 25 EMDAC

May 23, 2016 jessica adams

Sanofi's insulin glargine and lixisenatide injection combination product and lixisenatide injection solo product for the treatment of adults with type 2 diabetes mellitus

MAY 24 EMDAC

May 20, 2016 jessica adams

Novo Nordisk''s NDA for insulin degludec and liraglutide injection for the treatment of adults with type 2 diabetes mellitus

MAY 5 AADPAC/DSRM

May 3, 2016 jessica adams

KemPharm's benzhydrocodone/acetaminophen oral tablets for short-term (up to 14 days) management of acute pain.

MAY 3-4 AADPAC/DSRM

April 27, 2016 jessica adams

Does the REMS with ETASU for ER/LA opioids assure safe use?

Is it not unduly burdensome to patient access to the drugs?

To the extent practicable, does it minimize the burden to the healthcare delivery system?

APR 25 PCNS

April 21, 2016 jessica adams

Sarepta's eteplirsen for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping

APR 12 ODAC

April 8, 2016 jessica adams

Clovis Oncology, Inc.'s rociletinib tablets for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test

APR 12 PEDAC

April 7, 2016 jessica adams

Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Information on the 2-day joint meeting of the Pediatric Advisory Committee, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees on September 15 and 16, 2016.