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

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

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

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

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

Sun Pharma gets FDA approval for new device to treat skin disease

Lupin receives USFDA approval for Rivaroxaban Tablets

Alembic Pharmaceuticals receives USFDA final approval for Rivaroxaban Tablets USP