Last Updated on December 31, 2023 by The Health Master
Biocon yesterday said its unit has received approval from the US health regulator to market a generic product called Mycophenolic Acid.
Biocon Pharma has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.
NDA is data to be submitted to the USFDA for approval of new generic medicines.
The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180 mg and 360 mg strengths.
This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.
Morepen gets USFDA nod for anti-allergy drug
USFDA approves new drug to help identify cancer lesions
USFDA grants accelerated approval for Vosoritide for injection
Zydus Cadila gets USFDA nod to market generic Cancer drug in US
Aleor Derma gets USFDA nod for Antibacterial Cream: Alembic
USFDA gives nod to Zydus Pharma for Eluxadoline Tablets
Procedure to obtain license for Commercial Testing Laboratories
Govt asks States to collaborate with proposed Medical Devices Parks
Morepen gets USFDA nod for anti-allergy drug
Roche develops new research Test Kits for Omicron variant
Booster dose of these 6 Vaccines safe, increases immunity: Study
DGFT notifies norms for Sodium Salicylate & Methylcobalamin
NPPA to hire 33 professionals for various levels of its operations
Govt to amend Drug Rules for list of colours permitted to…
NPPA fixes retail price of 47 formulations: November 2021
Latest Notifications regarding Pharmaceuticals
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:
