USFDA

Dr. Reddy’s Laboratories Ltd. has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL) and Metaxalone Tablets which are approved by the U.S. Food & Drug Administration (USFDA).

Zydus Cadila has received the final approval from the USFDA to market Donepezil Hydrochloride Tablets, in the strength of 23 mg. The drug is indicated for the treatment of dementia of the Alzheimer’s disease.

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The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Zydus Cadila has received the final approval from the USFDA to market Candesartan Cilexetil Tablets USP and Ziprasidone Hydrochloride Capsules

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors. Nearly one in three people with hemophilia A develop inhibitors to standard factor VIII replacement therapies, which limits treatment options and increases the risk of life-threatening bleeds and repeated bleeds, particularly in joints, that cause long-term damage.

Zydus Cadila has received the final approval from the USFDA to market Telmisartan and Hydrochlorothiazide Tablets USP, in the strengths of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg.

Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its Nikita™ (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

Zydus Cadila has received the final approval from the USFDA to market Temozolomide Capsules in strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg.

Amgen announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Desonide Cream, 0.05%, the generic version of Desonide Cream, 0.05% of Perrigo New York Inc.