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
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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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
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