Cypress Pharmaceutical announced today that the Food and Drug Administration (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). Both products are indicated for the relief of cough and symptoms associated with the common cold.
ZUTRIPRO™ and REZIRA™ Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant. The approval of ZUTRIPRO™ and REZIRA™ Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 1990.
These products will be marketed by Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical, Inc.
"Currently, there are very few prescription products for patients suffering from cough and the symptoms associated with the common cold," said Chris Smith, EVP of Sales for Hawthorn Pharmaceuticals. "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."
ZUTRIPRO™ and REZIRA™ Oral Solutions are available through all national drug wholesalers, as well as chain drug stores and other distribution channels and will begin shipping immediately. ZUTRIPRO™ and REZIRA™ Oral Solutions are available by prescription only in the United States.
ZUTRIPRO™ (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) Oral Solution (CIII) is indicated for the relief of cough and nasal congestion associated with common cold and relief of upper respiratory allergy symptoms including nasal congestion in adults 18 years of age and older.