Lupin, Natco receive US FDA approval for Eribulin Mesylate Injection
ANDA approval covers Eribulin Mesylate Injection, the bioequivalent of Halaven Injection, for metastatic breast cancer and…
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Browsing Tag
US FDA approval
Wockhardt secures US FDA approval for ZAYNICH
Antibiotic approved for treatment of adults with complicated urinary tract infections caused by susceptible Gram-negative…
Lupin receives US FDA approval for generic colonoscopy preparation tablets
Approval grants Lupin 180-day generic drug exclusivity for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in…
Lupin receives US FDA approval for Dapagliflozin tablets
Approval confirms bioequivalence to Farxiga for approved indications
Biocon receives US FDA approval for Liraglutide Injection gSaxenda
Approval covers 18 mg/3 mL prefilled pens for chronic weight management in the United States
Lupin receives US FDA approval for Brivaracetam Oral Solution 10 mg/mL
Company initiates US launch following ANDA approval for bioequivalent to Briviact
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
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