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FDA nod for Breckenridge migraine tablets

31 Dec 2012, BioSpectrum Bureau , BioSpectrum

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Singapore: US-based Breckenridge Pharmaceutical received approval from the US FDA for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate tablets. The firm is expected to launch the drug immediately.

The tablets are being manufactured and supplied by Natco Pharma, India, and will be available in both 5 mg and 10 mg strengths. Rizatriptan Benzoate tablets are AB rated to Maxalt, a $320 million dollar brand drug marketed by Merck. Maxalt is a prescription medicine indicated for the acute treatment of migraines.