New Delhi: Drug firm Aurobindo Pharma has received final approval from the US Food and Drug Administration (FDA) to manufacture and market its oral contraceptive Levonorgestrel tablets.
"The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levonorgestrel tablet, 1.5 mg," Aurobindo Pharma said in a statement.
The approved abbreviated new drug application (ANDA) is generic version of Teva Branded Pharmaceutical Products R&D, Inc's Plan B One-Step tablets, it added.
The product has an estimated market size of $64 million for the twelve months ending October 2015 according to IMS, Aurobindo Pharma said.
The company currently has a total of 221 ANDA approvals (193 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from the US health regulator (FDA), it added.
Shares in Aurobindo Pharma, on Wednesday, ended 1.39 per cent lower at Rs 786.65 apiece on the BSE, whose benchmark Sensex index finished down 1.08 per cent.
Essential Business Intelligence, Continuous LIVE TV, Sharp Market Insights, Practical Personal Finance Advice and Latest Stories — On NDTV Profit.
