Drug Approval | November 23, 2021
U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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
This product will be manufactured at Lupin’s Pithampur facility In India
According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021
Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020
Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.
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