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
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
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
Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,
These observations are procedural in nature and none of them are related to data integrity
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
The Subsidiary has received one inspectional observation in Form 483
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
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