Drug Approval | August 28, 2024
Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Also received tentative approval for 137 mg
Also received tentative approval for 137 mg
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
The inspection was concluded with zero observations
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
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