Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, has received final approval for their abbreviated new drug application (ANDA) by the US FDA for norethindrone and ethinyl estradiol, USP 0.4 mg/0.035 mg tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc. The product will be marketed under the trade name Briellyn and distribution is expected to start immediately.
Glenmark remains the only Indian company to be granted an ANDA approval for an oral contraceptive product in the US. Today’s approval marks the fourth female hormonal product authorised for distribution in the US.