NEW DELHI: Drug firm Aurobindo Pharma has received final approval from the US health regulator 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 USFDA, it added.