Ranbaxy Laboratories, India's largest drugmaker, has received marketing approval to sell the low-cost version of GlaxoSmithKine's anti-migrane drug, Imitrex (Sumatriptan) in USA.

 

The USFDA has given approval for sell of Imitrex in 100 mg dosage with 180-day marketing exclusivity. Earlier the company had missed its December 2008 launch date because it did not get approval from the US drug regulator.

 

According to an estimate the 100 mg dosage accounts for about 60-65% of Imitrex's total sales in the US. Thus Ranbaxy can potentially earn $25-30 million during the 180-day exclusive marketing period.

 

A person close to the development said that, the company received the marketing approval from its Ohm facility in the US.

 

Ranbaxy had announced in January 2008, that it has reached an out-of-court settlement with GlaxoSmithKline (GSK), which allowed the Indian company to launch the generic version of Imitrex.

 

But, following the ban on two of its manufacturing facilities in India from where it proposed to make the drug, it did not receive USFDA's approval, and missed the launch date.

 

Ranbaxy will now make the drug in its US facility and has applied for a new marketing permission there.