Aurobindo Pharma gets USFDA’s nod for Felodipine extended-release tablets

18 Jan 2013 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Felodipine Extended-release Tablets USP 2.5mg, 5mg, and 10mg. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

Felodipine extended-release tablets USP 2.5mg, 5mg, and 10mg is the generic equivalent of AstraZeneca’s Plendil Extended-release Tablets, 2.5mg, 5mg and 10mg and indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS. Aurobindo now has a total of 172 ANDA approvals (147 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Aurobindo Pharma Share Price

1259.35 18.65 (1.50%)
23-Dec-2024 12:08 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1823.00
Dr. Reddys Lab 1347.85
Cipla 1479.80
Lupin 2179.75
Zydus Lifesciences 977.20
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.