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US FDA Approval

Panacea Biotec Ltd receives EIR from USFDA for Oncology plant at Malpur, Baddi

Mumbai, March 15, 2018: Pharma Major, Panacea Biotec Ltd. has announced the receipt of Establishment Inspection Report (EIR) from the U.S. Food & Drug Administration ('USFDA') indicating the formal closure of the Inspection conducted by USFDA, at its Pharmaceutical...

Tuberculosis -The Scourge Of India By Dr. Shalu Verma Kumar, CORE Diagnostics

New Delhi, March 14, 2018: Tuberculosis (TB) is an infectious disease variously named consumption, white plague, phthisis, or scrofula. It has been rampant in India, with the first cases being reported as early as 1500 BCE. As we celebrate the...

USFDA finishes pre-endorsement investigation at Biocon Malyasia

Mumbai, February 24, 2018: Pharma Noteworthy, Biocon said that USFDA has finished a pre-endorsement investigation of its assembling office in Malaysia and issued a Frame 483 with 6 perceptions According to the typical desires of the organization, we plan to...

FDA approves device to automatically manage diabetes

Washington, October 02, 2016: Federal regulators have approved a first-of-a-kind implant that can help some diabetes patients manage their disease, freeing them from the ordeal of constantly monitoring their blood sugar. The so-called artificial pancreas continuously measures blood sugar and...

Glenmark Pharmaceuticals receives ANDA approval for Diclofenac Sodium Gel, 3%

Mumbai, September 20, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Diclofenac Sodium Gel, 3%, the generic version of Solaraze® Gel, 3% of Fougera Pharmaceuticals...

Aurobindo Pharma receives USFDA Approval for Linezolid Injection

New Delhi, August 29, 2016: Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Linezolid Injection, 600 mg/300 mL (2 mg/mL). The...

Jubilant Life Sciences receives ANDA approval for Telmisartan Tablets

New Delhi, August 29, 2016: Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that it has received Abbreviated New Drug Application (ANDA) final approval for Telmisartan Tablets, USP 20,40 and 80mg, the generic...

Lupin Receives FDA Approval for Potassium Chloride Extended-Release Capsules

Mumbai, August 17, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin) has received final approval for its Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750...

Liquid Biopsy Devices Gain Traction Amid Ongoing Intensive Oncological Research

New Delhi, July 18, 2016: In an official press release on June 1, 2016, the U.S. Food and Drug Authority (FDA) sanctioned regulatory approval to the first ever blood-based assay, cobas EGFR mutation Test v2, for the drug Tarceva....

Zydus receives approval from USFDA to initiate Phase 2 clinical trials of Saroglitazar in...

Ahmedabad, June 07, 2016: Zydus Cadila, a research-driven, global healthcare provider, today announced that USFDA has approved the company’s plan to initiate a Phase 2 clinical trial of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver. This randomized,...