Drug Approval | December 18, 2023
Zydus receives final approval from the USFDA for Lacosamide Tablets
Lacosamide is indicated to treat partial-onset seizures
Lacosamide is indicated to treat partial-onset seizures
Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The product will be manufactured at Lupin's Pithampur facility in India
The company makes its maiden entry into Azerbaijan’s pharmaceutical market
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome
The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
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