Bio-pharmaceutical company ANI Pharmaceuticals Inc (ANI) (Nasdaq: ANIP) revealed on Monday that the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20mg/5mL has received U.S. Food and Drug Administration (FDA) approval,
The company said that Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac.
According to healthcare data and analytics provider IQVIA/IMS Health, the current annual US market for Fluoxetine Oral Solution is approximately USD14.6m, ANI stated.
ANI develops, manufactures and markets high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical needs.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML