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 cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA
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
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
The group has a total of 320 ANDA approvals
It had an estimated market size of US $ 32 million as of June 2021
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
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