my personal edition > pulmonary other > news


  E-Mail this DGNews to a colleague

DGNews

FDA Approves New Strength Of Mucinex (Guaifenesin) Tablet

FORT WORTH, TX -- January 21, 2003 -- Adams Laboratories, Inc., a provider of specialty pharmaceuticals for respiratory care, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for the 1200 mg strength tablet of Mucinex™ , a single-entity, long-acting guaifenesin product that will be available without a prescription. Mucinex provides the maximum therapeutic daily dosage of guaifenesin for adults by taking one 1200 mg tablet, or two 600 mg tablets, every 12 hours. It is indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

The FDA approval of Mucinex 1200 mg is Adams Laboratories' second product approval in six months. In July of last year, the FDA approved the company's NDA for the Mucinex 600 mg tablet -- the first long-acting guaifenesin product to have an NDA approved by the FDA. As a result of the Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act which stipulates that a drug product cannot be marketed simultaneously both as a prescription and as a nonprescription product at the same strength and same dosage and for the same indication, the FDA issued warning letters on October 11, 2002, deeming all extended release guaifenesin tablets without an approved abbreviated new drug application (ANDA) or NDA illegal and misbranded.

John Q. Adams Sr., Chairman and Chief Executive Officer, stated, "The FDA approval of our Mucinex 1200 mg tablet marks Adams Laboratories' second major drug approval in the past several months, and demonstrates the company's ability to leverage our unique regulatory strategy and proprietary technology to build a strong pipeline of respiratory products. Our large, knowledgeable sales force will continue to aggressively market both the 600 mg and 1200 mg Mucinex tablets to physicians and pharmacists in order to capture as much of the $3.2 billion cough, cold and flu market as possible. In addition, we will continue to expand our respiratory franchise with NDA submissions for Mucinex combination products this year."

Mucinex is available "behind the counter" from pharmacists nationwide, with or without a physician's recommendation. It works by loosening phlegm (mucus) and thinning bronchial secretions to rid the bronchial passageways of bothersome mucus -- making coughs more productive. Mucinex combines extended-release and immediate-release features in a single tablet.

ABOUT ADAMS LABORATORIES:
Based in Fort Worth, Texas, Adams Laboratories, Inc. develops, markets and sells prescription and non-prescription pharmaceuticals for the treatment of respiratory disorders and diseases. In addition to Mucinex, the Adams Laboratories product portfolio includes the Aquatab(R) line of guaifenesin-based cough and cold products and the ALLERx line of products to treat allergic rhinitis. Adams Laboratories seeks to become the leading specialty provider of pharmaceuticals for the treatment of a broad range of respiratory diseases via a business development strategy that combines product development, acquisitions and in-licensing tactics. More information can be found on the company's website at http://www.adamslaboratories.com .


SOURCE: Adams Laboratories, Inc.

E-Mail this DGNews to a colleague

To print, use this version