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Results For "United-States-Food-and-Drug-Administration"

448 News Found

Zydus receives final approvals from USFDA for Ivermectin Tablets USP
Drug Approval | March 02, 2026

Zydus receives final approvals from USFDA for Ivermectin Tablets USP

Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans


Lupin receives EIR from FDA for its Goa facility
Drug Approval | February 28, 2026

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025


Caplin Steriles gets USFDA approval for Sodium Phosphate injection
Drug Approval | February 25, 2026

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake


Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg
Drug Approval | February 19, 2026

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension


USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
Drug Approval | February 17, 2026

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.


Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility
Drug Approval | February 05, 2026

Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility

Inspection included drug device combinations covering our recent filing in nasal sprays domain


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Zydus receives final approval from USFDA for Eltrombopag Tablets
Drug Approval | January 16, 2026

Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad