Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
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
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death
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