Last Updated on October 17, 2024 by The Health Master
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg).
Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD).
It is used to prevent the worsening of symptoms in people with severe COPD. The drug will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad, (India).
Roflumilast Tablets, 250 mcg had annual sales of $34 million in the United States (IQVIA MAT Feb. 2023).
The group now has 363 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
USFDA gives nod for Azithromycin, used in bacterial infections
USFDA gives nod for Acetazolamide Tablets USP
USFDA gives approval for Carbidopa and Levodopa Tablets USP
USFDA gives approves for Tenofovir Alafenamide Tablets
USFDA gives approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%
USFDA gives ANDA approval for Gabapentin tablets
USFDA concludes inspection at Piramal Pharma, issues EIR
Pharmacy Inspectors appointed to check presence of Pharmacists at Medical Stores
HM Haryana urges Centre to provide Vial Monitor indicators for storage of vaccines
Hospital sealed for patient’s death due to Anaesthesia overdose
New Portable Medical Device developed to check vascular health
CDSCO: Submit application for license for Class C&D non-notified Medical Devices
Wet Granulation vs Dry Granulation: Understanding the Key Differences
CDSCO revises list of FDCs declared as rational
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: