Late-breaking news: Prescription cold medications gain FDA approval

June 17, 2011

FDA approved a new drug application for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII) and Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII), according to a statement issued by Cypress Pharmaceutical.

FDA approved a new drug application (NDA) for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII) and Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII), according to a statement issued by Cypress Pharmaceutical. Both products are indicated for the relief of cough and symptoms associated with the common cold and are available by prescription only in the United States. The drugs will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical.

The drugs are the only FDA-approved hydrocodone cough and cold combinations containing a nasal decongestant, and the NDA approval marks the first by FDA for a liquid hydrocodone cough medication since 1990, the press release noted.

Zutripro is indicated for the relief of cough and nasal congestion associated with the common cold and relief of upper respiratory allergy symptoms including nasal congestion in adults 18 years of age and older.

Rezira is indicated for the relief of cough and nasal congestion associated with the common cold in adults 18 years of age and older.

“Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold,” said Chris Smith, executive vice president of sales for Hawthorn Pharmaceuticals in a press release. “With Zutripro and Rezira Oral Solutions, healthcare practitioners finally have more options when treating patients suffering from a cough and symptoms associated with the common cold. Additionally, Zutripro and Rezira both contain a decongestant, which is very beneficial considering the fact that one of the most common symptoms of the common cold is nasal congestion.”