Glenmark gets final USFDA nod for oral contraceptive pills
New Delhi: Glenmark Pharmaceuticals on Tuesday said it has received final approval by the US health regulator to market its oral contraceptive Desogestrel and Ethinyl Estradiol tablets in the American market.
Glenmark Generics Inc USA, a subsidiary of Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Desogestrel and Ethinyl Estradiol tablets, Glenmark Pharmaceuticals said in a statement.
The company will market their approved product as Viorele TM Tablets and plans to commence shipping immediately, it added.
The approval is for Desogestrel and Ethinyl Estradiol tablets in the strength of 0.15 mg/0.02 mg and for Ethinyl Estradiol tablets in the strength of 0.01 mg.
Viorele TM Tablets are generic version of Teva Women's Health Inc Mircette tablets, Glenmark said.
"According to IMS Health for the 12 month period ending December 2011, the total market sales achieved for Desogestrel & Ethinyl Estradiol tablets USP 0.15 mg/0.02 mg and Ethinyl Estradiol Tablets USP 0.01 mg were approximately USD 98 million," it added.
The company's current portfolio consists of 78 generic products authorised for distribution in the US market and 40 ANDA's pending approval with the USFDA.
Glenmark shares were trading at Rs 309 in the afternoon trade on BSE, up 1.38 percent from its previous close.