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
Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg
It is part of the company’s pain/analgesics portfolio of OTC products
The company has already embarked upon significant expansion in Turkey
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
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
It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
The company has launched Perampil, at 2 mg (Rs. 49/strip of 7 tablets), 4 mg (Rs. 180/strip of 15 tablets) and 6 mg (Rs. 300/strip of 15 tablets) to improve patient access
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
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