USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

Now approved for both acute and chronic HCV in adults and children aged 3 and above

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)

UK MHRA approves aumolertinib to treat non-small cell lung cancer

Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)

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