Drug Approval | March 22, 2025
SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
TB treatment coverage in India increased by 32% in the last eight years from 53% in 2015 to 85% in 2023
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m
Experts urge early detection & better access to care
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