FDA Approves HYDROXYZINE HYDROCHLORIDE — Saptalis Pharmaceuticals, LLC.

**June 11, 2026** – Saptalis Pharmaceuticals, LLC has received FDA approval for its Abbreviated New Drug Application (ANDA 220271) for Oral Hydroxyzine Hydrochloride. This win is expected to bolster the company’s generic revenue pipeline by intensifying competition in the anti-anxiety market, driven by the anticipated increase in market share once the patent exclusivity period concludes.