Ranbaxy receives nod from USFDA to market Sumatriptan Succinate Tablets

Ranbaxy Laboratories has received final approval from US Food and Drug Administration (USFDA) to manufacture and market Sumatriptan Succinate Tablets, 25 mg (base) and 50 mg (base).

The office of Generic Drugs, USFDA has determined the Ranbaxy formulation to be bioequivalent and gave the same therapeutic effect as that of the reference listed drug Imitrex by GlaxoSmithKline.

The total annual market sales for Sumatriptan Succinate 25 mg and 50 mg tablets were $379 million (IMS MAT: June 2009) which is indicated for the acute treatment of migraine attacks with or without aura in adults.

This FDA approval represents the sixth such authorisation to commercialise product to be granted by the agency so far in 2009. This product will be launched immediately to all classes of trade. The company further expands its product portfolio of affordable generic product formulations that will be of benefit to patients, healthcare professionals and the US healthcare systems.

Ranbaxy Laboratories headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable, generic medicine. The company serves its customers located in 125 counties and has an expanding international portfolio of affiliates, joint venture and alliances, ground operation in 49 countries and manufacturing operations in 11 countries.