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• By Saptalis
• November 11, 2025

Saptalis Pharmaceuticals Launches Fluoxetine Oral Solution, USP 20 mg/5 mL

• By Saptalis
• June 18, 2025

Saptalis Pharmaceuticals, LLC is pleased to announce the commercial launch of Fluoxetine Oral Solution, USP 20 mg/5 mL, a prescription-only selective serotonin reuptake inhibitor (SSRI) developed to treat a range of mental health conditions effectively. This oral formulation is designed to support flexible and individualized treatment, particularly for patients who experience difficulty swallowing solid dosage forms.

https://www.businesswire.com/news/home/20250618093628/en/Saptalis-Pharmaceuticals-Launches-Fluoxetine-Oral-Solution-USP-20-mg5-mL

Saptalis Pharmaceuticals Announces the Launch of LIKMEZ® — The First and Only US FDA-Approved Ready-

• By Saptalis
• May 20, 2025

Saptalis Pharmaceuticals LLC proudly announces the launch of LIKMEZ® (metronidazole) oral suspension, 500 mg/5 mL (100 mg/ mL), an innovative liquid formulation developed specifically for patients with difficulty swallowing, or taste sensitivities. LIKMEZ® reinvents a widely prescribed antibiotic, addressing common adherence challenges and providing a convenient therapeutic option. This innovative formulation is protected by two U.S. patents, covering its unique taste-masking composition and its broad, accessible therapeutic applications.

https://www.businesswire.com/news/home/20250520874040/en/Saptalis-Pharmaceuticals-Announces-the-Launch-of-LIKMEZ-The-First-and-Only-US-FDA-Approved-Ready-to-Use-Oral-Suspension-of-Metronidazole

Saptalis Announces FDA Approval of Metronidazole Vaginal Gel, 0.75%

• By Saptalis
• December 31, 2024

Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Metronidazole Vaginal Gel, 0.75% (”Product”). Saptalis’s Product is therapeutically equivalent to the Reference Listed Drug (RLD), Metrogel - Vaginal®, 0.75%, Bausch Health.

Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis.

Saptalis’ Product is available in 70 gm tubes packaged with 5 vaginal applicators. The current annual U.S. market for Metronidazole Vaginal Gel, 0.75% is approximately $34 million, according to the latest estimates from IQVIA/IMS Health, with 1.7 million units sold annually.

Saptalis’s Metronidazole vaginal gel product is manufactured at its facility in Hauppauge, NY and will be launched in the next few weeks.