FDA CRL - Azurity Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Azurity Pharmaceuticals, Inc. for their New Drug Application (NDA 213593) for omeprazole and sodium bicarbonate for oral suspension. Submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the application cannot be approved in its current state due to identified product quality and clinical deficiencies.The FDA cited insufficient product quality controls, specifically stating the proposed control strategy does not adequately assure the identity, strength, purity, quality, and bioavailability of the drug. Key issues include inadequate assurance of sodium bicarbonate strength throughout the product's shelf-life and in-use period, an unvalidated assay method that may inaccurately measure the active ingredient, and a lack of data demonstrating consistent adherence to acceptance criteria. For omeprazole, concerns were raised regarding the assurance of strength and uniformity in the constituted suspension, with different assay procedures used without demonstrated comparability. An in-process control also needs to be established.Clinically, the application lacks sufficient data to support the proposed indication for "reduction of risk of upper gastrointestinal bleeding in critically ill patients," specifically requiring data for administration via nasogastric and orogastric tubes.Required actions include revising specifications, validating analytical procedures for both active ingredients, providing extensive stability data for various product configurations, establishing in-process controls, and submitting the requested clinical data for tube administration. The company must also update prescribing information, resubmit the proprietary name, and provide a comprehensive safety update.