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
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
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
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea
Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections
Announces Rs. 317 crore investment in new recycling plant
Subscribe To Our Newsletter & Stay Updated
