Glenmark Pharmaceuticals on Monday 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 per cent,” 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 $40 million, Glenmark said.
“Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid—responsive dermatoses,” it added.
Shares of Glenmark Pharmaceuticals closed at Rs 494.80 apiece on the BSE, down 5.78 per cent from the previous close.