Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received final approval for its Topiramate tablets in 25mg, 50mg, 100mg and 200mg strengths from the US Food and Drug Administration (US FDA).
With this, Aurobindo now has 94 abbreviated new drug application (ANDA) approvals from the US FDA, including 26 tentative approvals.
Topiramate tablets, the generic equivalent of Ortho McNeil Janssen Pharmaceuticals’ Topamax tablets, are indicated for the treatment of epilepsy in both children and adults.
It has a market size of approximately $2.3 billion for the 12 months ended September 2008, according to Newport, Aurobindo said in a filing to the BSE on Monday.