Drug Approval | August 23, 2024
Wanbury receives EIR from FDA for Patalganga facility
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India
This marks the first regulatory approval worldwide for nasally-delivered epinephrine
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
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
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