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 discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Fluralaner invented by Nissan Chemical is the active pharmaceutical ingredient of BRAVECTO and EXZOLT,
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
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
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