Drug Approval | 14 May 2025
Briefs: Zydus and CuraTeQ Biologics
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
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
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)
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
This approval authorizes the company to export Ibuprofen to the Chinese markets
The inspection concluded with 6 observations and none of them were related to Data Integrity
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
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
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