Aurobindo Pharma gets ANDA approval for Levonorgestrel Tablet

From USFDA

Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levonorgestrel Tablet, 1.5 mg.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Plan B One-Step Tablet of Teva Branded Pharmaceutical Products R&D, Inc.

Levonorgestrel Tablet is an oral contraceptive used for prevention of pregnancy. The approved product has an estimated market size of US$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 Aurobindo now has a total of 221 ANDA approvals (193 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

 

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