Zydus U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets, 250 mcg (US RLD – DALIRESP?).
Zydus being one of the first applicants for Roflumilast Tablets, 500 mcg is eligible for 180 days of shared generic drug exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act.
Zydus Roflumilast Tablets are indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The drug will be manufactured at the groups formulation manufacturing facility at the SEZ, Ahmedabad.
Powered by Capital Market – Live News
Related Tags
IIFL Customer Care Number
(Gold/NCD/NBFC/Insurance/NPS)
1860-267-3000 / 7039-050-000
IIFL Capital Services Support WhatsApp Number
+91 9892691696
Download The App Now
Follow us on
2025, IIFL Capital Services Ltd. All Rights Reserved
IIFL Capital Services Limited - Stock Broker SEBI Regn. No: INZ000164132, PMS SEBI Regn. No: INP000002213,IA SEBI Regn. No: INA000000623, SEBI RA Regn. No: INH000000248, DP SEBI Reg. No. IN-DP-185-2016
ARN NO : 47791 (AMFI Registered Mutual Fund Distributor)
This Certificate Demonstrates That IIFL As An Organization Has Defined And Put In Place Best-Practice Information Security Processes.
