News | August 21, 2025
NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
Glenmark USA is named in multiple antitrust and consumer protection lawsuits, including class actions, consolidated in the Eastern District of Pennsylvania, U.S
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
The companies admitted taking part in the cartel in exchange for reduced fines but Alchem did not settle
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
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