The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
The study observed 2,648 girls, of which 2,300 completed the standard 45-day programme
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
Vonoprazan is used in the treatment of disorders related to Gastroesophageal Reflux Disease (GERD)
Innovative product offerings to capitalise on emerging opportunities within and beyond the sexual wellness market
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
The approval further adds to Biocon’s portfolio of complex drug products
TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA
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