Tuesday 2 July 2013

Glenmark gets final US approval for anti-migraine drug

Glenmark Pharma  's US generics subsidiary has received final approval from US Food and Drug Administration for Rizatriptan Benzoate orally disintegrating tablets, used to treat migraine headaches.

Rizatriptan ODT is a generic version of Merck's Maxalt MLT Tablets and Glenmark said it will start shipping its tablets immediately.

The company has approval to sell the tablets in 5mg and 10mg strengths.

Rizatriptan ODT had sales of USD 263 million for the year ended March 2013, Glenmark said, citing IMS Health data.

The company 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 were trading up 0.11 percent at Rs 569.00 on BSE.

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