Last Updated on October 15, 2024 by The Health Master
Mumbai: Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Obeticholic acid tablets, 5 mg and 10 mg.
The new Lupin tablets are the generic equivalent of Ocaliva tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals Inc, indicated for primary biliary cholangitis.
As per IQVIA MAT December 2022, the Obeticholic Acid tablets (RLD Ocaliva) had estimated annual sales of $255 million in the US.
USFDA gives approval for this Antifungal drug
USFDA grants accelerated approval for Skin cancer therapy
USFDA gives approval for Calcipotriene and Betamethasone foam
USFDA gives approval for Brexpiprazole tablets
USFDA gives approval for generic Rocuronium Bromide Injection
USFDA gives approval for Prochlorperazine Maleate Tablets USP
Drug recall: 55,000 bottles of Colchicine tablets due to this reason
USFDA gives approval for this Antifungal drug
Drug Control Dept launches WhatsApp helpline number: Tamil Nadu
Proposal to regulate prices of non-scheduled drugs under consideration
Govt Job: For B.Pharm as Bench Chemist at CDSCO
USFDA issues Form 483 with 2 observations to Alembic, Gujarat
Difference: Disintegration and Dissolution test in pharma industry
How to prepare SOPs in the Pharma Industry
Difference between branded and generic medicines
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
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:
