Drug Approval | October 19, 2021
Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
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
U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
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
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
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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