New Delhi: Glenmark Pharmaceuticals on Thursday said it has received approval from US health regulator to market a generic oral contraceptive and a gel for treating skin inflammation in the American market.
Glenmark Generics Inc, subsidiary of Glenmark Generics has been granted final approval for two abbreviated new drug approvals (ANDA's) from the United States Food and Drug Administration (USFDA), Glenmark said in a statement.
The approvals are for Ciclopirox Gel 0.77 per cent and Levonorgestrel & Ethinyl Estradiol tablets USP, 0.15 mg/0.03 mg, it added.
"Glenmark will market the approved oral contraceptive as Marlissa tablets and plans to commence shipping both products immediately," the company said.
Marlissa is a generic version of Duramed Pharmaceuticals Nordette tablets. Ciclopirox is the generic version of Medicis Pharmaceutical Corporation's Loprox Gel and is available in 30, 45, and 100 gram tubes.
"The gel is indicated for the topical treatment of seborrheic dermatitis of the scalp and according to IMS Health sales data for the 12 month period ending September 2011, Ciclopirox Gel garnered annual sales of greater than USD 10 million," Glenmark said.
According to IMS Health, for the 12 month period ending September 2011 total market sales achieved for Levonorgestrel and Ethinyl Estradiol tablets USP, 0.15 mg/0.03 mg were nearly USD 50.84 million.
The company's current portfolio consists of 76 products authorised for distribution in the US market, it said.
Shares of of Glenmark were trading at Rs 311 on the BSE in the afternoon trade, up 0.91 per cent from previous close.