Drug Approval | December 16, 2021
Sun gets US FDA approval for generic amphotericin B injection
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
The tablets are indicated for the treatment of pulmonary arterial hypertension
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
The company is moving towards complex and more differentiated products
The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA
Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
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