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- Congressional legislation signed in November 2025 requires FDA to issue guidance by May 2027 to improve the clarity and predictability of prescription-to-OTC drug switch applications. - The new law establishes formal meeting pathways for companies to align with FDA on data requirements and study designs needed to support drug switches from prescription to over-the-counter status. - Pharmaceutical companies including Kenvue, Perrigo, and Opella are urging FDA to reduce regulatory complexity, citing the current switch process as rigorous as a new drug application with lengthy back-and-forth discussions. - Commissioner Makary has authorized substantial hiring for nonprescription drug efforts and stated FDA will cut red tape to deliver more safe and affordable OTC drugs.
- Perrigo has secured FDA approval for its over-the-counter store brand equivalent of Nexium 24HR (esomeprazole magnesium capsules). - A patent litigation settlement with AstraZeneca allows Perrigo to launch its generic esomeprazole product in late September 2017. - The generic medication offers consumers a cost-effective alternative for treating frequent heartburn, occurring two or more days a week. - Annual retail sales for Nexium 24HR capsules have exceeded $300 million, indicating a substantial market for the generic option.
