Sandoz contraceptive granted regulatory approval
PRINCETON, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Sandoz, the company said.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the FDA approval of Introvale (levonorgestrel and ethinyl estradiol), a generic version of Duramed’s Seasonale.
Branded and generic versions of Seasonale had sales of around $91 million during the 12-month period ended in November, according to IMS Health.