News
Rondec® Does Not Contain Carbinoxamine
Alpharetta, GA - The following is Alliant Pharmaceuticals’ response to the June 8, 2006 news release from the Food and Drug Administration (FDA) regarding its actions to strengthen efforts on unapproved prescription drug products.
The Guidance for FDA Staff and Industry “Marketed Unapproved Drugs-Compliance Policy Guide” is the FDA’s final document regarding the marketing of unapproved drugs.
The first enforcement action taken under this guidance is to stop the manufacturing of unapproved carbinoxamine-containing products.
Mark Pugh, CEO and President of Alliant Pharmaceuticals, a pediatric specialty pharmaceutical company, says he supports the new policy. Rondec®, a medication for cold and allergy symptoms, was reformulated in December 2004 and does not contain carbinoxamine.
We have requested that the websites be updated with Rondec®’s current formulation in order to reassure consumers that Rondec® is a safe product.
Currently Rondec®-DM Oral drops and syrup contain chlorpheniramine maleate, phenylephrine hydrochloride, and dextromethorphan hydrobromide. The Rondec® Oral drops and syrup contain chlorpheniramine maleate and phenylephrine hydrochloride.