USFDA

Dr. Reddy’s announced that its US subsidiary, Promius PharmaTM, has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA).

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental.

Vertex Pharmaceuticals announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.

Vizient, Inc.  has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing  on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).

Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.

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Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.

Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.

Takeda Pharmaceutical Company Limited  and H. Lundbeck A/S announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).