MADISON — Cypress Pharmaceutical announced the Food and Drug Administration (FDA) has 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 19901.
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, executive vice president of sales for Hawthorn.
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.
Source: Cypress Pharmaceutical