Aurobindo Pharma receives USFDA nod for Naproxen, Dexmedetomidine and Ibandronate

Hyderabad based generic drug major Aurobindo Pharma in a three different stock exchange filing informed of receiving USFDA approval for three drugs namely Naproxen Sodium Tablets, Dexmedetomidine Hydrochloride Injection and Ibandronate Sodium Tablets. All the products are expected to be launched in Q1 FY2016-17.

Naproxen Sodium Tablets approved ANDA is bioequivalent and therapeutically equivalent of Bayer Healthcare LLC. Naproxen Sodium Tablets is used in the treatment and prevention of osteoporosis in post-menopausal women.  As per global drug sales tracking agency IMS, for the twelve months ending January 2016 the estimated market size of USD 96 million.

This is the 66th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.

Dexmedetomidine Hydrochloride Injection approved ANDA is bioequivalent and therapeutically equivalent of Hospira Inc. The Injection is used as a sedation of non-intubated patients prior to and/or during surgical and other procedures. The approved product has an estimated market size of USD 59.1 million for the twelve months ending January 2016 according to IMS.

This is the 27th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products.

Ibandronate Sodium Tablets approved ANDA is bioequivalent and therapeutically equivalent of Hoffman-La Roche Inc. Ibandronate Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women. The sanctioned product has an estimated market size of USD 55 million for the twelve months ending January 2016 according to IMS. This is the 65th ANDA (including 14 tentative approvals) to be approved out of unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.

Of late the pharma major has received nod for many of its generic drugs helping it build a strong portfolio of drugs in an all-important US markets. The drugs in case will add incremental revenues to the top-line which will be reflected in its Q1 FY17 earnings. Responding to the drug approvals Aurobindo Pharma shares has rallied more than 10 per cent in the past one month after hitting lows in February 2016. The scrip was trading with gains of 2.16 per cent at Rs 736.10 on NSE.