Last Updated on October 10, 2024 by The Health Master
Aurobindo Pharma announced that its step-down subsidiary company, Aurolife Pharma LLC., has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w.
Diclofenac Sodium Topical Solution USP, 2% w/w is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC (Horizon).
The product is expected to be launched in Q1FY24. According to IQVIA, the approved product has a market size of around US$ 487 million for the twelve months ending December 2022.
This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products.
Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.
Diclofenac Sodium Topical Solution USP, 2% w/w is Indicated for the treatment of the pain of osteoarthritis of the knee(s).
USFDA approves this anemia drug for patients on dialysis
USFDA gives nod for Technetium Mertiatide Injection
USFDA tentative nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide tablets
USFDA approves this drug for rare blood cancer
USFDA gives approval for Amphetamine capsules
USFDA gives tentative approval Acalabrutinib capsules, 100 mg
Pharma Industry announced to stop producing medicines: Pakistan
USFDA issues 2 observations to Natco Pharma for Vizag facility
NABL alerts all Testing Laboratories regarding misrepresentation of NABL symbol
Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)
NPPA fixed Ceiling price of 1 scheduled formulation: February 2023
Drug recall: 5,720 tubes of Clobetasol Propionate Cream recalled due to this reason
NPPA revised Ceiling price of 53 scheduled formulations: February 2023
Latest IPC Alert – Indian Pharmacopoeia Commission
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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: