Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
The product will be launched in Q1FY26
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The company does not expect this development to have any material impact on the current business operations
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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