Drug Approval | December 20, 2023
Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
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
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