FDA Approves NDA for Two Hydrocodone Cough and Cold Medications From Cypress Pharmaceuticals

From reading the press release these are the only two hydrocodone drugs that also a nasal decongestant and this is the first approval of a liquid hydrocodone drug since 1990. We all know what hydrocodone is by it’s “pill” name, Vicodin. The subsidiary of Cypress, Hawthorn Pharma will be doing the sales and distribution of the 2 drugs and of course these are prescription only drugs. BD

MADISON, Miss.--(BUSINESS WIRE)--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 decongestant¹. 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, 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.²”