Glenmark, Natco get final US nod for anti-migraine drug
Rizatriptan Benzoate orally disintegrating tablets are a generic version of Merck's Maxalt MLT Tablets.
Glenmark Pharma's US generics subsidiary and another generics drugs maker Natco Pharma have received final approval from US Food and Drug Administration for Rizatriptan Benzoate orally disintegrating tablets, used to treat migraine headaches.
Both the companies have approval to sell the tablets in 5mg and 10mg strengths.
Rizatriptan ODT is a generic version of Merck's Maxalt MLT tablets and Glenmark said it will start shipping its tablets immediately.
Natco said it has already started shipping the product launched by its marketing partner Breckenridge Pharmaceuticals.
Rizatriptan ODT had sales of USD 263 million for the year ended March 2013, Glenmark said, citing IMS Health data.
Glenmark now has 87 products authorized for distribution in the US market and 53 ANDAs (abbreviated new drug application) are pending approval with the drug regulator.
Glenmark shares ended up about 1 percent at Rs 575.35 on NSE on Tuesday. Natco ended up 1.5 percent at Rs 454.65.