Drug Approval | December 21, 2021
U.S. FDA approves ANI’s rifabutin capsules, launch soon
The capsules are the generic version of the reference listed drug Mycobutin
The capsules are the generic version of the reference listed drug Mycobutin
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 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
Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA
The group has a total of 320 ANDA approvals
According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
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