Drug Approval | October 18, 2023
Glenmark receives ANDA approval for Apremilast Tablets
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
Lupin enters into BTA with Lupin Manufacturing Solutions
Tagrisso is projected to be a pivotal contributor to AstraZeneca’s portfolio
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
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