New Delhi: Drug maker Ranbaxy Laboratories said Tuesday it has received final approval of the US health watchdog to manufacture and market in the country Sumatriptan Succinate Tablets used for the treatment of migraine attacks.
The company has received the Food and Drug Administration approval to manufacture and market Sumatriptan Succinate Tablets in the US in 25 mg and 50 mg strengths, Ranbaxy said in a statement.
With this approval, Ranbaxy has expanded the product portfolio of Sumatriptan tablets as the company had already got the FDA nod to launch the drug in 100 mg strength.
“We are pleased to receive this final approval for Sumatriptan Succinate Tablets 25 mg and 50 mg in addition to the 100 mg that was previously approved,” Ranbaxy Laboratories vice-president, trade sales, North America, Bill Winter said.
The office of generic drugs, USFDA, has determined that the Ranbaxy formulations to be bio-equivalence and have same therapeutic effect as that of GlaxoSmithKline’s patented drug Imitrex, Ranbaxy said.
Ranbaxy in January last year had said that it would launch the drug 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 the USFDA.
Industry estimates put total annual sales of Imitrex at around $1 billion, with the 100 mg strength tablets accounting for more than $650 million. The 25 mg and 50 mg strength of the drug has a market of around $350 million per annum in the US.
Ranbaxy Pharmaceuticals Inc is a US-based wholly owned subsidiary of Ranbaxy Laboratories. Ranbaxy Pharmaceuticals is engaged in the sale and distribution of generic and branded prescription products in the US heathcare system, the filing added.