FDAnews Drug Daily Bulletin

The FDA is expanding its proposed ban on ozone-depleting substances (ODSs) in metered-dose inhalers (MDIs) to include OTC epinephrine inhalers such as Wyeth’s Primatene Mist.

In a proposed rule published in the Sept. 20 Federal Register, the FDA intends to remove the essential-use designations for epinephrine MDIs by Dec. 31, 2010, effectively banning the use of such products in 2011.

“All of the evidence before us indicates that epinephrine can be formulated into a drug product that does not release ODSs,” the FDA said in the rule. “However … we are especially interested in receiving public comment concerning any such technical barrier that may exist.”

The FDA convened the Pulmonary-Allergy Drugs and Nonprescription Drug advisory committees last year to discuss the effects of lifting essential-use designations for the products. At the meeting, Wyeth said it had been trying to reformulate Primatene Mist so it does not emit ODSs but ran into difficulties while avoiding patented designs of such reformulations held by 3M and GlaxoSmithKline.

The FDA disagreed. “We could not find any evidence that Wyeth could not obtain patent licenses or arrange for contract manufacturing by a patent holder,” the FDA said.

In addition, the FDA highlighted 3M’s success in reformulating Proventil (albuterol) as an ozone-safe formulation.

The FDA proposed banning the use of ODSs in several other asthma inhalers earlier this year. The rule can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/cd0612.pdf.