Unichem Labs gets USFDA nod for migraine tablets
New Delhi : Drug firm Unichem Laboratories said it has received approval from the US health regulator for its Rizatriptan Benzoate tablets used for the treatment of migraine.
The company "has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT, 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg," Unichem Laboratories said in a filing to BSE.
The tablets are generic versions of Merck & Company Inc's Maxalt MLT tablets 5mg & 10mg and Maxalt tablets 5mg, 10mg, it added.
The product will be commercialised from the company's Goa plant. Active Pharmaceutical Ingredient will also be made in-house at Roha API Plant, Unichem Laboratories said.
The tablets are indicated for acute treatment of migraine in adults and in pediatric patients of 6 to 17 years of age.
Shares of Unichem Laboratories were trading at Rs 264.10 in the afternoon trade on BSE, up 0.40 per cent from its previous close.