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.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives.