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

456 News Found

Cipla’s generic Ventolin HFA secures USFDA approval
Drug Approval | April 23, 2026

Cipla’s generic Ventolin HFA secures USFDA approval

Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market


Lupin launches Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in USA
Drug Approval | April 23, 2026

Lupin launches Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in USA

The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling


Medtronic launches adaptive deep brain stimulation system for Parkinson’s in India
Medical Device | April 23, 2026

Medtronic launches adaptive deep brain stimulation system for Parkinson’s in India

The system is powered by BrainSense technology, which has received approval from USFDA


Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection
Drug Approval | April 17, 2026

Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions


Lupin receives FDA’s tentative approval for Sugammadex injection
Drug Approval | March 31, 2026

Lupin receives FDA’s tentative approval for Sugammadex injection

Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery


Zydus receives USFDA approval for cevimeline hydrochloride capsules
Drug Approval | March 14, 2026

Zydus receives USFDA approval for cevimeline hydrochloride capsules

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.


APL Healthcare’s Unit-IV classified as VAI by the USFDA
News | March 14, 2026

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed


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