Migraine drug: Natco Pharma submits application for generic version of Rimegepant Sulfate tablet with USFDA
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Telangana: Natco Pharma Limited has announced the submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Rimegepant Sulfate tablet Eq 75mg base strength.
Rimegepant is currently indicated for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults. Migraine is a neurological condition characterized by recurrent headaches that are moderate to severe in intensity.
Rimegepant Sulfate tablets are marketed in the United States (US) by Pfizer Inc. under the brand name NURTEC ODT. Natco has been named as defendant in a lawsuit filed in the United States district court for the district of Delaware by Pfizer Inc. and Pfizer Ireland pharmaceuticals.
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