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
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
Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults
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)
Nelarabine is in a class of medications called antimetabolites
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
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