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FDA approves Eton’s application for hydrocortisone oral solution

Eton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval as a replacement therapy for children ...

Mirum Pharmaceuticals Announces Health Canada Authorization of LIVMARLI® for the Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepat…

Health Canada Authorizes Mirum's LIVMARLI® for the Treatment of Cholestatic Pruritus in Patients with Progressive Familial ...
Nasdaq

Amneal Gets FDA Approval For Sodium Oxybate Oral Solution

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) Thursday said that the U.S. Food and Drug Administration (FDA) has approved its sodium oxybate oral solution which references Jazz Pharmaceutical's ...

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") prepares for the launch of PYQUVI™ (deflazacort) oral suspension, the first of a new branded-generic rare disease ...

Aucta Pharmaceuticals is pleased to announce the late January launch of PYQUVI oral suspension 22.75 mg/mL. PYQUVI, a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in ...
Monthly Prescribing Reference

FDA to Review Oral Solution Formulation of Desmopressin

The FDA has assigned a Prescription Drug User Fee Act target date of February 25, 2026 to the application. The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ET-600 ...
Morningstar

Mandara Biopharma Files IND with the FDA to Advance Dronabinol Oral Solution Formulation for Alzheimer's Agitation

BOULDER, Colo., Jan. 12, 2026 /PRNewswire/ -- Mandara Biopharma Inc., a privately held U.S.-based biopharmaceutical company focused on novel therapies for central nervous system (CNS) disorders, today ...
Nasdaq

Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution

BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium ...
Monthly Prescribing Reference

Vigafyde, a Ready-to-Use Vigabatrin Oral Solution, Now Available

Credit: Pyros Pharmaceuticals. Vigafyde is supplied as a peppermint-flavored oral solution in a 150mL bottle. Vigafyde ™, a ready-to-use oral solution formulation of vigabatrin, is now available for ...
Business Wire

Cypress Pharmaceutical, Inc. Receives FDA Approval of Levetiracetam Oral Solution

MADISON, Miss.--(BUSINESS WIRE)--Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company’s abbreviated new drug ...
Medical Dialogues

Indoco Remedies Receives USFDA Approval for Lacosamide Oral Solution ANDA

Mumbai: Indoco Remedies Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated ...
Benzinga.com

Eton Pharma Plans FDA Filing For ET-600 Oral Desmopressin Next Month, Eyes 2026 Launch

On Friday, Eton Pharmaceuticals, Inc (NASDAQ:ETON) revealed results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for central ...