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

465 News Found

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection
Drug Approval | May 14, 2025

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy


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