USFDA

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy.

Pharma Major Lupin announced that it has received final approval for its Metronidazole Tablets USP, 250 mg and 500 mg from the United States Food and Drug Administration (FDA) to market a generic version of G.D. Searle LLC's Flagyl® Tablets, 250 mg and 500 mg.

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).