Teva receives tentative approval for breast cancer drug
JERUSALEM The Food and Drug Administration has given tentative approval to Teva Pharmaceutical Industries for its generic version of a breast cancer treatment, the Israeli drug maker announced Thursday.
The agency gave Teva the tentative approval for letrozole tablets in the 2.5-mg strength, a generic version of Novartis’ Femara. Femara has annual sales of $556 million, according to IMS Health.
A tentative approval means that the generic drug meets the conditions for approval, but can’t be launched until the expiration of the patent, which will happen in June 2011.