Single-ingredient, extended-release prescription guaifenesin products must be removed from the market by the end of November if they have not been approved by FDA, the agency states in Feb. 25 letters to 66 marketers and distributors of the drugs.

In line with that deadline, FDA directs manufacturers of the cough treatment to cease production no later than May 21 and refrain from resuming manufacturing until the agency approves an application for a company's particular products.

Distribution of unapproved single-ingredient guaifenesin extended-release products may continue until Oct. 23, the agency states.

The deadline represents a limited grace period for exhausting product supplies and responds to a request from several of the companies involved. The 66 manufacturers and distributors were the recipients of FDA warning letters in October 2002 directing immediate removal of the drugs from the market.

The warning letters were prompted by the agency's approval in July of a single-ingredient guaifenesin 600 mg extended-release product for OTC use - Adams Labs' Mucinex (¹ Also see "Adams Mucinex Approval Spurs FDA Crackdown On Guaifenesin Products" - Pink Sheet, 21 October, 2002., p. 5).

In the warning letters, FDA noted the Rx expectorant is not a medical necessity and voiced its confidence that Adams Labs could meet the demand for the extended-release product. In addition, immediate-release guaifenesin is "widely available" OTC, the agency pointed out.

Recipients of the letters subsequently filed a joint citizen petition requesting the agency permit continued marketing while drug approval applications are prepared (² Also see "FDA Guaifenesin Crackdown Based On Adams Labs NDA “Improper” – Petition" - Pink Sheet, 18 November, 2002., p. 10).

The petition urged the agency to publish a Federal Register notice explaining why a change in the status of the unapproved products is necessary. The notice also should provide "specific guidance concerning required applications and necessary studies" and include a schedule for submission and approval of applications, according to the petition.

The agency decided on the terms of the grace period, FDA says, following a meeting between Commissioner Mark McClellan, MD/PhD, and representatives of the warning letter recipients.

The agency plans to publish a Federal Register notice within about 60 days "further describing its enforcement policy with respect to unapproved drugs," the letter states.

The notice will pertain especially to drugs that were subject to the Drug Efficacy Study Implementation (DESI) program and are covered by the agency's compliance policy guide governing new drugs marketed without approved NDAs or ANDAs.

"The goal of this notice is to bring unapproved drugs into compliance with the new drug approval requirement without placing an undue burden on consumers or industry," FDA explains.

The notice will clarify that in certain circumstances, FDA will provide a grace period when one company obtains approval of an NDA for a product that other companies are marketing without approval. However, "companies marketing unapproved drugs should not expect a grace period to protect them from the necessity of leaving the market for some period of time while obtaining approval," the letter maintains.

The letter also notes "FDA's voluntary decision to publish a notice in the Federal Register does not confer a legal right to such notice, through such means, in all similar situations."

In the past, the letter acknowledges, the agency has published notices stating applications are required for unapproved drugs when such drugs were medically necessary. The agency also has released similar notices for pre-1962 approved drugs or those identical, related and similar to them (DESI drugs).

Adams was recently granted approval for Mucinex 1,200 mg guaifenesin extended-release tablets. The company also plans to submit NDAs in 2003 for respiratory products combining dextromethorphan with guaifenesin and pseudoephedrine with guaifenesin, according to the firm (³ 'The Tan Sheet' Jan. 27, 2002, In Brief).

Rx Extended-Release Guaifenesin Must Exit Market By November, FDA Says

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