APR 23 AAC

March 20, 2018 jessica adams

Baricitinib tablets, submitted by Eli Lilly and Company, proposed for the treatment of adult patients with moderately 5 to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate

APR 19 PCNS

March 2, 2018 jessica adams

Cannabidiol oral solution, sponsored by GW Pharmaceuticals, proposed for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older

MAR 27 PDAC

March 1, 2018 jessica adams

Lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment

MAY 10 EMDAC

February 26, 2018 jessica adams

Volanesorsen solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc., proposed as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

MAR 7 ODAC

February 23, 2018 jessica adams

Supplemental biologic license application for BLINCYTO (blinatumomab) injection, submitted by Amgen, Inc., proposed for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.

MAR 21-22 BPAC

February 21, 2018 jessica adams

Reclassification of certain Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) diagnostics. Presentations about research programs at the FDA's Center for Biologics Evaluation and Research (CBER).

MAR 1 VRBPAC

February 13, 2018 jessica adams

1) Recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 U.S. influenza season 2) Overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA

FEB 8 ACHDNC

February 8, 2018 jessica adams

Issues related to newborn screening (NBS) and the diagnosis and treatment of individuals with heritable disorders

MAR 5-6 RCAC

January 17, 2018 jessica adams

Impact of labeling under the Pregnancy and Lactation Labeling Rule

FEB 14 AADPAC

January 16, 2018 jessica adams

sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia

JAN 11 AMDAC

January 12, 2018 jessica adams

Ciprofloxacin dispersion for inhalation by Aradigm Corp.

JAN 10 BRUDAC

January 10, 2018 jessica adams

Oral testosterone undecanoate capsules by Lipocine Inc.

MAR 5-6 RCAC

January 10, 2018 jessica adams

Impact of labeling under the Pregnancy and Lactation Labeling Rule

FEB 14 AADPAC

January 10, 2018 jessica adams

sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia