Corporate News     08-Mar-17
Unichem Laboratories receives ANDA approval for Rizatriptan Benzoate ODT &
From USFDA
Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg which are therapeutically equivalent to Maxalt – MLT Tablets 5mg & 10mg and Maxalt Tablets 5mg 10mg of Merck & Company, Inc.

Rizatriptan Benzoate Tablets USP, 5mg & 10mg and Rizatriptan Benzoate ODT USP, 5mg & 10mg; is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine in adults and in pediatric patients 6 to 17 years of age.

The product will be commercialized from Unichem's Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant.

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