Drug Approval | December 27, 2021
Lupin receives U.S. FDA approval for Sevelamer Carbonate
This product will be manufactured at Lupin's Goa facility in India
This product will be manufactured at Lupin's Goa facility in India
The capsules are the generic version of the reference listed drug Mycobutin
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
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
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