Glenmark gets USFDA nod for generic Desoximetasone Ointment

Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for its generic Desoximetasone Ointment and will commence the shipping of the product immediately.

"Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Desoximetasone Ointment USP, 0.25%," Glenmark Pharmaceuticals said in a statement.

The company's  Desoximetasone Ointment USP is the generic version of Taro Pharmaceuticals USA Inc's Topicort and shipping will commence immediately, it added.

According to IMS Health sales data for the 12-month period ending June 2013, Desoximetasone Ointment garnered annual sales of nearly USD 40 million, Glenmark said.

"Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses," it added.

The company currently has 89 products authorised for distribution in the American marketplace and 54 ANDA's are pending approval with the USFDA, Glenmark said.

Shares of Glenmark Pharmaceuticals today closed at Rs 494.80 apiece on the BSE, down 5.78% from the previous close.