Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
The approved ANDA is therapeutically equivalent to the reference listed drug product
The approved ANDA is therapeutically equivalent to the reference listed drug product
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
The product will be launched in March 2024
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