Drug Approval | August 11, 2024
Zydus receives final approval from USFDA for Valbenazine Capsules
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
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