Zydus secures tentative USFDA approval for Rifaximin Tablets 550 mg
The tablets, used for treating IBS-D in adults, will be manufactured at the company’s SEZ II facility in Ahmedabad
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Browsing Tag
US FDA approval
Cipla receives US FDA approval for generic version of Abraxane
Cipla secures final USFDA approval for Protein-bound Paclitaxel 100 mg/vial; launch planned in H1 FY26 in the US market
Biocon Biologics secures US FDA approval for Biosimilar Bevacizumab, JOBEVNE
The approval marks Biocon Biologics’ seventh biosimilar clearance in the US, expanding its oncology portfolio in one of the…
Gland Pharma secures US FDA approval for Latanoprost Ophthalmic Solution
Product targets treatment of high intraocular pressure in glaucoma and ocular hypertension patients
Zydus Lifesciences receives U.S. FDA approval for Scopolamine Transdermal System
Zydus gains final approval to market Scopolamine Transdermal System, marking its fifth ANDA approval in the transdermal portfolio…
US FDA approves Acer Therapeutics’ genetic disorder drug
The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard…
US FDA approves Mirati’s lung cancer drug
Mirati was seeking approval for the drug for treating patients with advanced lung cancer who have stopped responding to other…
US FDA gives final approval to Alembic Pharma’s Desonide cream
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis
US FDA gives final approval to Alembic Pharma’s Diclofenac Sodium Topical Solution
Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knees
US FDA approves JB Pharma’s generic Venlafaxine extended-release tablets
The product is based on Osmotic Controlled Release Oral Delivery System (OROS) technology, an advanced and precision controlled…