Drug Approval | August 17, 2021
Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder
It’s an AB-rated generic therapeutic version of Durezol
SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial
The company is eligible for 12 months exclusivity from launch
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
Nearly 6,000 patients have been treated with the drug since 2017
Deal signed with AOP Orphan for US commercial rights
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