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By November, Mucinex will be only long-acting, single ingredient guaifenesin legally available

FORT WORTH, TEXAS, March 4, 2003 -- Adams Laboratories, a provider of specialty pharmaceuticals for respiratory care, has commented on the FDA's follow-up statement to the agency's October 2002 warning letter for manufacturers and distributors of unapproved long-acting, single-entity guaifenesin.

Specifically, in July 2002, the FDA approved a New Drug Application (NDA) for a single ingredient guaifenesin 600 mg extended release drug product Mucinex, produced by Adams Laboratories. Following this approval, the FDA reviewed the marketing status of all strengths of single ingredient extended release guaifenesin products and determined that all such unapproved products should no longer be marketed in light of the existence of an FDA approved product.

The October 2002 warning letter explained that single ingredient guaifenesin extended release drug products are new drugs and require an approved NDA for legal marketing under the Federal Food, Drug, and Cosmetic Act. The FDA stresses that the extended release guaifenesin is not dangerous. Rather, the goal of this notice is to clarify the FDA's views about unapproved drugs and emphasize that illegally marketed drugs must obtain FDA approval.

On February 26, 2003, to enforce this original letter, the FDA issued clarification letters to sixty-six manufacturers and distributors of unapproved single ingredient guaifenesin extended release products, delineating explicit timeframes and guidelines. The FDA concluded that any unapproved products were on the market illegally and although they will be allowed a brief grace-period, they must abide by the following regulations and deadlines:

  • Manufacturers of unapproved single ingredient guaifenesin extended release products must cease production no later than May 21, 2003, and shall not resume that manufacturing until FDA approves an application covering the manufacture of the particular products
  • Distribution of the unapproved drug products (including distribution by secondary wholesalers or other distributors) is not permitted after October 23, 2003
  • Retail sales of the unapproved drug products are not permitted after November 30, 2003

Subsequently, Mucinex will become the only single ingredient, long-acting guaifenesin approved for marketing in the U.S.

Mucinex provides the maximum therapeutic daily dosage of guaifenesin for adults by taking two 600 mg tablets or one 1200 mg tablet 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.

Source: Adams Laboratories

Posted: March 2003