Aurobindo Pharma gets USFDA nod for oral contraceptive tablets
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.
"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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd