Piramal Pharma completes USFDA inspection of Aurora facility with Zero Form-483 observations

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA

Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP

Allopurinol is used to prevent or lower high uric acid levels in the blood

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne

Lupin receives USFDA approval for Rivaroxaban Tablets

Alembic Pharmaceuticals receives USFDA final approval for Rivaroxaban Tablets USP

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy

Wanbury's Tanuku facility granted GMP certificate by ANVISA

The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)

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

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

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

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)