Aurobindo Pharma gets USFDA nod for oral contraceptive tablets
Advertisement
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 website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.