Edwards Pharmaceuticals, Inc – FDA Warning Letter

This FDA Warning Letter, NO. 2010-NOL-09, was issued to Edwards Pharmaceuticals, Inc. following an FDA inspection of a contract manufacturer, (b)(4), which revealed that Edwards Pharmaceuticals distributes drug products manufactured by (b)(4). The letter highlights that certain drug products, specifically Ed-Chlor Tan Caplets and Ed ChlorPed Pediatric Suspension Drops, are "new drugs" lacking FDA-approved applications, as required by Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act).

These products are considered new drugs because they are not generally recognized as safe and effective for their intended uses. Furthermore, as prescription drugs intended for conditions not amenable to self-diagnosis, their labeling fails to bear adequate directions for laymen, rendering them misbranded under Section 502(f)(1) of the Act. The introduction or delivery of these products into interstate commerce without approved new drug applications violates Sections 301(a) and (d) of the Act. Additionally, the products are deemed adulterated under 21 USC 351(a)(2)(B).

Edwards Pharmaceuticals is responsible for investigating and correcting these violations and preventing recurrence. Failure to promptly correct the violations may result in legal action, including seizure and injunction. The firm must respond in writing within 15 working days, detailing corrective actions, steps to prevent recurrence,