US FDA approves Ranbaxy's generic sumatriptan
The US subsidiary of Indian drugmaker Ranbaxy has received final approval from the U. Food and Drug Administration to manufacture and market sumatriptan succinate tablets, 25mg (base), and 50mg (base), which is indicated for the acute treatment of migraine attacks with or without aura in adults.
The FDA's Office of Generic Drugs has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex by UK drug giant GlaxoSmithKline. Total annual market sales for sumatriptan succinate 25mg and 50mg tablets in the USA were $379 million for the 12 months to June, according to IMS Health data.
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