Aurobindo Pharma Ltd has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate orally disintegrating tablets.
The tablet is the generic equivalent of Merck & Co Inc’s Maxalt MLT ODT for the treatment of migraine in adults and in paediatric patients.
The annual sale of the product was approximately $271 million for 12 months ended April as per IMS, the Hyderabad-based company said in a release on Tuesday.
The product was approved out of Unit VII (SEZ) formulations facility in Hyderabad. The product was ready for launch, the company said.
Meanwhile, Natco Pharma Ltd has obtained marketing approval for its Rizatriptan Benzoate (Maxalt-MLD) orally disintegrating tablets for the US market.
The drug is used in the treatment of migraine headache with or without warning signs that occur prior to the onset of headache.
The company had already commenced shipments of the product which was being launched by its marketing partner, Breckenridge Pharmaceuticals.
Natco estimates the market to be around $250 million (before generic launch – as of December 2012).