Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
Sales reflect continued strong growth in oncology and vaccines
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