Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1 per cent), Glenmark Pharmaceuticals said in a statement.
Glenmark Pharmaceuticals has received final approval from the US health regulator for its generic Fluocinonide cream used for treating a variety of skin infections.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd, has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluocinonide cream USP (0.1 per cent), Glenmark Pharmaceuticals said in a statement.
"According to IMS Health sales data for the twelve-month period ending March 2014, Fluocinonide cream garnered annual sales of approximately USD 103 million," it added.
The company's product is the generic version of Medicis's Vanos cream.
"Fluocinonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses," Glenmark said.
The company's current portfolio consists of 93 products authorised for distribution in the US market and it has 71 ANDA's pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were today trading at Rs 546.35 per scrip in the morning trade on BSE, up 1.34 per cent from its previous close.
Glenmark stock price
On July 15, 2014, Glenmark Pharma closed at Rs 546.75, up Rs 7.60, or 1.41 percent. The 52-week high of the share was Rs 640.35 and the 52-week low was Rs 489.10.
The company's trailing 12-month (TTM) EPS was at Rs 15.99 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 34.19. The latest book value of the company is Rs 107.14 per share. At current value, the price-to-book value of the company is 5.10.
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