Generics manufacturer Armstrong Pharmaceuticals now has until the end of 2011 to remove Primatene Mist and private-label epinephrine inhalers from the market.

In a Federal Register notice published Nov. 19, FDA granted a request made by Armstrong and others to extend a proposed deadline by one year to the end of 2011 to allow consumers more time to find prescription alternatives to epinephrine-containing metered-dose inhalers, if an OTC alternative is not developed by then.

The ¹ final rule that goes into effect Dec. 31, 2011 - the Use of Ozone-Depleting Substances; Removal of Essential-Use Designation - amends the agency's regulation on the use of ODSs in self-pressurized containers.

The rule finalizes a proposal FDA issued in September 2007 that essentially requires companies to reformulate without chlorofluorocarbons or remove their products from the market (² Also see "Primatene Mist To Be Unavailable After 2010 – Proposed Rule" - Pink Sheet, 24 September, 2007., p. 7).

The agency removes the "essential-use designation" for ODS CFCs in epinephrine-containing MDIs, which are currently the only MDIs available OTC for the treatment of asthma or another disease.

"FDA has concluded that there are no substantial technical barriers to formulated epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs" as of the effective date, the agency says.

When Armstrong, a wholly owned subsidiary of Amphastar Pharmaceuticals based in West Roxbury, Mass., bought Wyeth's epinephrine-containing inhaler Primatene Mist earlier this year, it became the sole OTC marketer impacted by the rule.

The amendment prohibits sales of the products after the effective date.

FDA says in the rule users of nonprescription epinephrine CFC MDI need time to find appropriate substitutes.

FDA also notes consumers using OTC MDIs may not interact with their health care providers to obtain information about the transition.

"Additional avenues of communication" will be needed to get the message out to the OTC users, including information on selecting a physician and finding the appropriate prescription drug programs and low-cost health care programs to access the Rx alternatives, according to the notice.

According to the notice, the extension will also give manufacturers time to step up production of prescription MDIs formulated with albuterol hydrofluoroalkane to ensure adequate supplies are produced for patients that need them, including consumers currently using OTC epinephrine MDIs.

HFA MDIs do not pose a threat to the "stratospheric ozone," FDA says. However, emissions of CFCs and other ODSs are damaging to the ozone.

At a December 2007 public meeting, Wyeth said it would phase out Primatene mist, while Armstrong said it would develop an OTC alternative that would be on the market by the end of 2011. Armstrong asked FDA to extend the deadline to allow the firm time to develop the alternative (³ Also see "Armstrong Wants Extra Year To Develop Inhaler Without Epinephrine" - Pink Sheet, 10 December, 2007., p. 15).

Armstrong then bought the rights to Primatene Mist in July, but Wyeth retained the rest of the Primatene line.

A spokesman for Amphastar said the Rancho Cucamonga, Calif.-based firm is not commenting on the MDI rule or other issues because it is preparing to conduct an initial public offering of shares.

Under the Clean Air Act, it is the responsibility of FDA and the Environmental Protection Agency to determine whether an ODS-releasing FDA-regulated product has an essential ODS use.

The rule follows recommendations made by FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs advisory committees at a January 2006 meeting (⁴ Also see "Primatene Mist Availability Not “Essential,” Advisory Panel Says" - Pink Sheet, 30 January, 2006., p. 7).

After discussion and speculation about barriers consumers may face if asthma medications were available only by prescription, committee members found the products did not warrant essential-use designation nor provide critical health benefit.

- Katie Stevenson (k.stevenson@elsevier.com)

Armstrong’s Primatene Mist Inhaler Has 2011 Deadline To Exit The Market

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