USFDA

The explosive growth of the Indian pharmaceutical industry over the last decade has made the nation the host of most FDA-approved plants outside the United States.
Leaders of two of India's largest drug manufacturers said the integration of electronic systems to avoid quality failures in factories is proceeding more slowly than expected, as industry intends to adapt to Enhanced regulatory oversight in developed countries.

Aurobindo Pharma USA Inc. recalls 47,040 bottles of Venlafaxine hydrochloride prolonged-release capsules in the 37.5 mg strength in a national recall in the US, the latest USFDA enforcement report said. The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad

The United States Food and Drug Administration (US FDA) issued a warning letter to Bangalore-based resonance laboratories for filthy manufacturing practices and gave 15 days of time for the company to shape up or ship out.

The prospect of a major change to the regulatory agency comes as drug makers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said  "stop" the launch of its drug Duchenne muscular dystrophy after American lawmakers questioned her $ 89,000 a year award.

President Trump promised to review the Food and Drug Administration could make major changes, including steps to accelerate the approval process of new prescription drugs, setting up a shock with critics who say its push for the Deregulation could put consumers at risk.

uniQure N.V. announced that AMT-060,  its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show sustained increases in Factor IX (FIX), reductions in FIX replacement usage and a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up. 

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VBX Stent Graft has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

Ironwood Pharmaceuticals, Inc. and Allergan plc  announced  that the U.S. Food and Drug Administration (FDA) has approved a 72 mcg dose of LINZESS®(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

Sunovion Pharmaceuticals Inc. (Sunovion)  announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Latuda® (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. LATUDA is also approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.