Ranbaxy gets USFDA nod for Imitrex

Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) for marketing generic version of anti migraine drug Imitrex in 100 mg strength after a delay of over a month.

The approval is for only the generic version of Imitrex to be manufactured by Ranbaxy's US subsidiary Ohm Laboratories at its plant at New Jersey in the US.

When contacted, a company spokesperson confirmed getting approval to market generic version of Imitrex in 100 mg strength in the US.

Ranbaxy in January last year had said that it might launch in December 2008 the 25 mg, 50 mg and 100 mg strengths of generic Imitrex in the US with an exclusivity period of 180 days after settling a patent litigation with GlaxoSmithKline (GSK). However, it was not able to launch the drug due to delay in getting approval from USFDA.

Industry estimates put Imitrex' total annual sales at around $1 billion, with the 100 mg strength tablets accounting for more than $650 million.