The FDA made one of its latest big moves in the name of patient safety on March 2. The agency called for the stop of sales of about 500 unapproved prescription allergy, cold, and cough medicines--some of which are extended-release drugs.
A part of the concern about the time-release treatments was that they might release active ingredients inconsistently, either exposing a patient's system to the drug too quickly or too slowly. Some of the medicines that the FDA wants to remove from pharmacy shelves went on the market prior a 1962 law that requires the FDA to judge the safety and efficacy of a treatment before it can be sold to patients, the Wall Street Journal reported.
While there were few if any big-named medicines in the agency's removal order, there are clearly some drug makers that will be affected by the action. Northvale, NJ-based Elite Pharmaceuticals, for example, said that it manufactures two of the impacted treatments--Lodrane 24 and Lodrane 24 D--which are sold by ECR Pharmaceuticals. And Elite made about $3 million or "substantially all" of its revenue during the nine months ending Dec. 31, 2010 on royalties from ECR Pharmaceuticals' sales.
The FDA has ordered makers of certain drugs to no longer produce the treatments 90 days after March 3 and to no longer ship them 180 days after March 3. Manufacturing other treatments within the order must stop immediately.
Some of the affected treatments, according to the FDA, include Aerohist extended-release tablets, Aquatab DM tablets extended release, and Certuss multilayer extended release tablets. Other impacted medicines, including Lodrane 24 D, are unapproved combinations of drugs.
- check out the FDA's release
- and Elite Pharmaceuticals' release
- read the story from BusinessWeek
- here's the WSJ article