Glenmark Generics USA has received final approval for two abbreviated new drug applications (ANDA) from US Food and Drugs Administration (FDA). The approvals are for an oral contraceptive and a dermatitis treatment gel.
The pharma major has received the go ahead to launch Marlissa tablets (Levonorgestrel & Ethinyl Estradiol tablets), a copy of Duramed Pharmaceuticals' Nordette tablets, used for prevention of pregnancy in women. The drug had sales of USD 50.84 million in US for year ending September 2011, Glenmark said citing IMS Health data.
This is Glenmark's 8th female hormonal product approved for distribution by US FDA, it said.
Earlier this week, Glenmark had recalled seven lots of generic norgestimate and ethinyl estradiol tablets (birth control pills), made in India and distributed in the US, due to a packaging error that could make the pills ineffective.
Meanwhile, the company has also received US FDA approval to launch Ciclopirox Gel, a copy of Medicis Pharmaceutical Corp. It is indicated for the topical treatment of seborrheic dermatitis of the scalp and had sales of over USD 10 million for year ended September 2011.
Glenmark said it plans to start shipping both products immediately.
Glenmark shares were up 0.8% at Rs 311 on NSE in morning trade.
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