Drug Approval | March 23, 2024
Zydus receives tentative approval from USFDA for Letermovir Tablets
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
New Bioprocessing Production Center in Daejeon to supply products to customers in Asia-Pacific for development and production of biologics
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
Acquisition to further expand the Alexion, AstraZeneca Rare Disease pipeline beyond complement inhibition
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager
The company will provide comprehensive response to USFDA for the observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
Group sales came in at 47.637 billion euros, down 1.2% on a currency- and portfolio-adjusted basis
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