Zydus receives PAS approval from US FDA for Mycophenolate Mofetil for injection
The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat
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Browsing Tag
US FDA approval
FDA approves first generic of Symbicort to treat asthma and COPD
Agency supports development of complex generic drug-device combination product to improve competition and access to more…
Zydus receives final approval from US FDA for Colestipol Hydrochloride tablets
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C…
Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of…
US FDA approves AstraZeneca-Merck’s Lynparza to treat early-stage breast cancer
The approval was based on results from a late-stage study in which the drug showed statistically significant and clinically…
Lupin gets US FDA nod to market generic drug
The product is the generic equivalent of Lundbeck Pharmaceuticals' Sabril for oral solution
Strides Pharma unit gets US FDA approval for generic product
The company's product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda…
Aleor Dermaceuticals receives US FDA final approval for Nystatin and Triamcinolone Acetonide…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Nystatin and Triamcinolone Acetonide…
US FDA approves expanded use of Bristol Myers cancer drug Opdivo
The approval was based on data from a late-stage study showing the drug along with chemotherapy improved event-free survival and…
US FDA approves cancer therapy by Johnson & Johnson and Legend Biotech
The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell…