Drug Approval | May 12, 2025
Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
The FDA issued Form 483 with one observation related to building and facility management
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
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