FDA gives Teva tentative approval to generic Maxalt, Evista

JERUSALEM, Israel The Food and Drug Administration has granted tentative approval to Teva for its generic version of Merck’s migraine drug Maxalt, in 5 mg and 10 mg, and Eli Lilly’s osteoporosis drug Evista, in 60 mg.

Maxalt’s generic, rizatriptan benzoate, will be launched when the brand’s patent expires in June 2012. Evista’s generic, raloxifene hydrochloride, will hopefully be launched once Teva settles patent litigation in the U.S. District Court for the Southern District of Indiana.

Evista had sales of about $691 million in the United States in 2007, and Maxalt had sales of about $193 million in the United States for 2007, according to IMS Health.

Also, Teva was informed that the FDA has concluded that its generic version of GlaxoSmithKline’s antidepressant Wellbutrin was safe and effective. Some patients had complained about experiencing depression after switching from the brand to the generic.

The FDA detected slight differences between Teva's formulation and the original, but said they were small enough to be inconsequential.