Glenmark unit bags USFDA nod for generic contraceptive drug
Press Trust of India / New Delhi Jul 22, 2010, 16:05 IST
Glenmark Pharmaceuticals today said it has received health regulator's nod to market and distribute generic contraceptive pills, Norethindrone Acetate, in the US market.
The approval for Norethindrone Acetate tablets in 5 mg strength, is granted by the US Food and Drugs Administration (USFDA) to Glenmark Generics Inc, a subsidiary of group firm Glenmark Generics, Glenmark Pharmaceuticals said in a statement.
The company will commence marketing and distribution of the product immediately, it added.
Norethindrone Acetate is the generic version of Duramed Research Inc’s 'Aygestin' and is also indicated for the treatment of secondary amenorrhea, endometriosis and abnormal uterine bleeding due to hormonal imbalance, it added.
"Today's approval marks the second product approval by the USFDA from Glenmark's hormone facility located in Goa," the company said.
According to IMS health, Norethindrone Acetate tablets garnered approximately $27 million in sales for the 12 month period ending March 2010. The US contraceptive market recorded sales of $4.5 billion in the 12 months ended December 2009.
The company's current portfolio consists 57 products authorised for distribution in the US market. It has over 50 Abbreviated New Drug Applications pending approval with the US health regulator.
Shares of Glenmark Pharmaceuticals were trading at Rs 281.35 on late afternoon trade on Bombay Stock Exchange, down 0.50 per cent from its previous close.
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Glenmark Pharmaceuticals today said it has received health regulator's nod to market and distribute generic contraceptive pills, Norethindrone Acetate, in the US market.
