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Center for Drug Evaluation and Research

FDA proposes suffix for biosimilar product names

FDA proposes suffix for biosimilar product names

WASHINGTON — Early feedback on the Food and Drug Administration’s proposal on naming conventions for biosimilars shows a mixed response. Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix unique for each product. For interchangeable

FDA OKs first drug for women’s sexual desire disorder

FDA OKs first drug for women’s sexual desire disorder

RALEIGH, N.C. — Sprout Pharmaceuticals Inc. has gained Food and Drug Administration clearance to market Addyi, which the company calls the first FDA-approved medication for hypoactive sexual desire disorder (HSDD) in women. Sprout said late Tuesday that Addyi (flibanserin, 100 mg) is slated to be released by Oct. 17. “It has been a remarkable journey to

Vertex’s Orkambi seen as breakthrough in treating cystic fibrosis

Vertex’s Orkambi seen as breakthrough in treating cystic fibrosis

BOSTON — The approval of Vertex Pharmaceuticals Inc.’s Orkambi (lumacaftor/ivacaftor) is being hailed as a big stride forward in the treatment of cystic fibrosis. The Food and Drug Administration announced its approval of the drug just before the holiday weekend. Vertex noted that the medication is the first to treat the underlying cause of cystic fibrosis in

Sandoz biosimilar receives backing of FDA panel

WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar. The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment. “This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available