Sun Pharma announces USFDA approval for Topamax tablets

NEW DELHI: Drug firm Sun Pharmaceutical Industries on Saturday said US health regulator Food and Drug Administration has approved its Abbreviated New Drug Application (ANDA) to market generic Topamax, topiramate tablets used in the treatment of partial onset seizures.

Topiramate tablets are the generic version of Topamax tablets from Ortho-McNeil Janssen Pharmaceuticals portfolio and are available in four strengths 25 mg, 50 mg, 100 mg, and 200 mg, the company said in a statement.

These strengths of Topamax tablets have annual sales of approximately $2.5 billion in the US, it added.