PHARMACEUTICALS EXPORT PROMOTION COUNCILOF INDIA(Set up by Ministry of Commerce & Industry, Govt., of India)

Date: 01st January 2013

Aurobindo gets USFDA nod for migraine drugAurobindo Pharma is set launch Rizatriptran Benzoate tablets, as it received an approval from the US food and drugs administration for 5 mg and 10 mg doses. The company will manufacture the product from its Unit VII formulations facility at Hyderabad.

These products are a copycat version of Merck’s Maxalt. It is used in the treatment of migraine in adults as well as pediatric patients. According to IMS, the annual sale of product is $300 million for the 12 months ending March.

Earlier last month, the drugmaker had also launched Ondansetron injections, which are a generic equivalent of GlaxoSmithKline’s Zofra. This product, which is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or postoperative nausea, will be manufactured from the Unit IV facility of Aurobindo.

The firm had also launched Abacavir Tablets, which is a generic equivalent of ViiV Healthcare Company’s Ziage, approved out of the Unit III formulations facility. Over 70 per cent of Aurobindo’s revenues come from global markets and it has eight manufacturing facilities in India.

Now, Aurobindo altogether has 171 ANDA approvals, which include 146 final approvals, of which two are from Aurolife Pharma, and 25 tentative approvals from the USFDA.Source: Financial Chronicle

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