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Aurobindo Pharma Ltd today said it has received tentative approval to manufacture and market Sumatriptan Succinate Tablets, which is used to treat acute migraine headaches, from the FDA
NEW DELHI, India | February 1, 2008 | Aurobindo Pharma Ltd today said it has received tentative approval to manufacture and market Sumatriptan Succinate Tablets, which is used to treat acute migraine headaches, from the US Food and Drug Administration (USFDA).
''We have received tentative approval to manufacture and market Sumatriptan Succinate Tablets from the USFDA in 25mg, 50mg and 100mg strengths,'' said a company statement.
The tablet is the generic equivalent of GlaxoSmithKline's Imitrex Tablets, which are prescribed for the treatment of acute migraine headaches, it added.
Annual sales of Sumatriptan Succinate Tablets in the US is about 950 million dollars, according to IMS Health data.
This is the company's 63rd ANDA approval from the USFDA, the statement said.
SOURCE: Aurobindo |
