Pharma firm Glenmark Pharmaceuticals today said its US-based subsidiary Glenmark Generics has received approval from US health regulator to market Norethindrone tablets used to prevent pregnancy.
Glenmark Generics has received approval from US Food and Drug Administration (US FDA) for Norethindrone tablets in 0.35 mg strength, Glenmark Pharma said in a filing to the Bombay Stock Exchange.
The product would be marketed under the trade name 'Heather' and distribution is expected to start immediately, the filing added.
"Heather represents our first launch of an oral contraceptive in the US and the first FDA approval on a product out of our hormone facility located in Goa, India," Glenmark Generics Ltd CEO Terrance Coughlin said.
Glenmark is currently the only Indian company to be granted an Abbreviated New Drug Application (ANDA) approval on an oral contraceptive product, it said.
Norethindrone tablets are oral contraceptive indicated for the prevention of pregnancy.
Glenmark also has impending ANDA approvals with US FDA of some more products in various stages of development in the oral contraceptive therapeutic segment, the filing added.
