FDA tentatively approves Sun’s bone cancer generic

ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a generic version of a bone cancer drug.

The agency announced the tentative approval of Sun Pharmaceutical Industries’ zoledronic acid injection in the 4-mg strength. The drug is a generic version of Novartis’ Zometa, which had global sales of $1.38 billion, according to Novartis financial data.

The FDA gives tentative approval to generic drugs that meet its conditions for marketability, but whose branded counterparts still have patent protection, thus preventing full approval until the patent expires. Novartis’ patent on Zometa will expire in 2012, according to the FDA’s Orange Book database.