Aurobindo Pharma gets US FDA nod for oral contraceptive and anti-platelet drugs

Aurobindo Pharma has announced that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levonorgestrel Tablet and Eptifibatide Injection. These drugs are expected to be launched in this month, the company informed in a exchange filing.

Levonorgestrel Tablet is an oral contraceptive used for prevention of pregnancy. The approved abbreviated new drug application (ANDA) is the generic version of Teva Branded Pharmaceutical Products R&D, Inc's Plan B One-Step tablets. The approved product has an estimated market size of USD 64 million for the twelve months ending October 2015 according to IMS. This is the 52nd ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.

Eptifibatide Injection is used in the treatment of acute coronary syndrome. It helps to prevent platelets in the  blood from sticking together and forming a blood clot causing heart related issues.The approved product has an estimated market size of USD 137 million for the twelve months ending October 2015 according to IMS.The approved new drug is the therapeutically equivalent to Schering Corporation's Integrilin injection. Aurobindo now has 18 ANDAs (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products.

With these, the company has received eight drug approvals in October-December quarter and within this, four approvals came in December itself. Reacting to these approvals the stock has been outperforming the broader market indices by giving returns in excess of 15 percent. Since its recent lows of Rs 691 in September it touched a high of Rs 860 by the end of October. The Stock is currently trading up 2 percent at Rs 795 after this news broke out. Going forward the company is going to financially perform well as these drug launches would translate into revenues and thus aid margins and profitability.

Aurobindo now has a total of 222 ANDA approvals (194 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

Aurobindo Pharma Limited manufactures generic pharmaceuticals and active pharmaceutical ingredients.The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergies. The Company is marketing these products globally, in over 150 countries.