FDA WARNING_LETTER - Ariad Pharmaceuticals

The FDA issued a warning letter to Alora Pharmaceuticals, LLC, concerning promotional communications for RELEXXII® (methylphenidate hydrochloride extended-release tablets), submitted by Osmotica Pharmaceutical US LLC. The inspection revealed that the sponsored links for RELEXXII were misleading, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). These communications failed to adequately present risk information, creating a false impression of the drug"s safety, which is critical given its classification as a Schedule II controlled substance with a high potential for abuse and serious health risks.

The FDA highlighted that the promotional materials omitted crucial risk information, despite the inclusion of statements directing to the drug"s full prescribing information. This omission is particularly concerning due to the drug"s boxed warning about potential abuse, misuse, and associated health risks, including addiction and overdose.

The FDA requires Alora Pharmaceuticals to take immediate corrective actions. These include ceasing misleading promotional activities, submitting a written response within 15 working days detailing plans to discontinue such communications, and providing a comprehensive plan for corrective communications. These communications should accurately address the misleading aspects and be disseminated through the same channels as the original promotions. Failure to comply may result in legal actions, including seizure and injunction. The company must ensure all promotional materials comply with the FD&C Act and FDA regulations.