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’s an AB-rated generic therapeutic version of Durezol
Deal signed with AOP Orphan for US commercial rights
It had an estimated market size of US $ 32 million as of June 2021
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg
The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana
Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules
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