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 Indian Pharmacopoeia Commission (IPC) has added 23 new impurities standards and 7 new Indian Pharmacopoeial Reference standards
Forty-two per cent Indian patients with Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) described “confusion about what I was supposed to do next” as an important barrier to early and accurate diagnosis
Acute therapies continue to report strong growth compared to chronic ones.
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
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