FDA grants application approvals for three generics to Glenmark

WASHINGTON The Food and Drug Administration granted application approvals to Glenmark Generics for three new generic drugs.

The drugs, including an ointment and a cream, each containing 0.1 percent mometasone furoate, and metformin hydrochloride tablets in 500 mg, 850 mg and 1,000 mg doses, will soon hit the U.S. market.

Mometasone furoate, marketed under the brand Elocon by Kenilworth, N.J.-based Schering-Plough, is a corticosteroid of medium potency used to treat dermatosis. Schering-Plough had total sales of $12.7 billion in 2007. Metformin hydrochloride, marketed by New York-based Bristol-Myers Squibb as Glucophage, is an oral antihyperglycemic drug used to manage Type 2 diabetes. Bristol-Myers Squibb had sales of $19.3 billion in 2007.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals, based in Mumbai, India.