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 approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
The company is confident of addressing the concern raised by the USFDA
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
It is the first autotaxin inhibitor to be investigated in cancer patients
The company will provide comprehensive response to USFDA for the observations
The inspection was concluded with few procedural observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
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