The Food and Drug Administration (FDA) has given the go-ahead for Glenmark Generics to sell its contraceptive drug Norethindrone in the US.
The product, the company’s version of NOR-QD has been approved in 0.35mg form.
Distribution is expected to commence immediately, with the treatment being marketed under the name Heather.
Glenmark chief executive officer Terrence Coughlin said: “This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the United States and the first FDA approval on a product out of our hormone facility located in Goa, India.”
The firm, a generic drug specialist, has a number of products awaiting FDA approval, in addition to several treatments in various stages of development.
Copyright Press Association 2010