New Delhi, July 23: Glenmark Pharmaceuticals today said it has received health regulator's nod to market and distribute generic contraceptive pills, Norethindrone, in the US market.
The approval for Norethindrone tablets in 0.35 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.
Norethindrone is the generic version of Ortho McNeil Janssen Pharmaceuticals Inc's 'Micronor' and is indicated for the prevention of pregnancy.
According to IMS Health, total sales of of this niche generic contraceptive product was USD 43 million for the 12 months period ended March 2010.
"This is Glenmark's third female hormonal product approval and it is the second approval for an oral contraceptive," the company said.