MADISON, Miss. — The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.
Cypress announced the approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) and Rezira (hydrocodone bitartrate and pseudoephedrine). Both drugs are oral solutions and, because they contain the opioid hydrocodone, are classified as schedule III controlled substances by the Drug Enforcement Administration. Cypress subsidiary Hawthorn Pharmaceuticals will market the drugs.
“Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold,” Hawthorn EVP sales Chris Smith said.
Cypress said the drugs are the only FDA-approved hydrocodone cough-cold combinations containing a nasal decongestant and that the approval marked the first time the FDA approved new hydrocodone cough medications since 1990.