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

403 News Found

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity
News | May 13, 2025

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Drug Approval | May 12, 2025

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


Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

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


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

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
Drug Approval | May 02, 2025

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)


Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | May 01, 2025

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Lupin receives USFDA approval for Tolvaptan Tablets
Drug Approval | April 24, 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Drug Approval | April 24, 2025

Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K


Lupin receives EIR from USFDA for its injectable facility in Nagpur
Drug Approval | April 17, 2025

Lupin receives EIR from USFDA for its injectable facility in Nagpur

The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older