Pliva Hrvastka gets tentative approval for argatroban

SILVER SPRING, Md. The Food and Drug Administration has given a tentative approval to a generic drug for treating heparin-induced thrombocytopenia, agency records show.

The FDA granted the authorization to Croatian drug maker Pliva Hrvastka for the generic injected drug argatroban. The agency also gave tentative approval to Teva’s version of the same drug. The branded version of the drug, also called Argatroban, is manufactured by GlaxoSmithKline and has annual sales of around $137 million, according to IMS Health.

A tentative approval means that a generic drug meets the conditions for full approval by the FDA, but it can’t yet be marketed because the patent has not expired. The patent for the drug will expire in 2011, according to the FDA.