MDI and Dose Counters – FDA Reaffirms Position

On April 10, 2014, FDA responded to a petition from Teva Respiratory LLC approving it in part and denying it in part.  Teva requested that FDA refuse to approve any rescue inhaler (generally metered dose inhalers (MDIs) of short-acting beta agonist like albuterol), brand or generic, unless it has a dose counter, and that FDA implement a plan to transition all currently approved rescue inhalers to versions incorporating a dose counter.

This was the second petition related to dose counters that FDA responded to for Teva, the first being on December 9, 2013 (making essentially the same requests), but specifically for any ANDA or 505(b)(2) application that referenced their ProAir (HFA) MDI as the basis for submission.  FDA responded at the time that it “would expect that any generic albuterol sulfate MDI to have a dose counter if the reference listed drug (RLD) had one.”

While the nature of the new petition is a bit broader, the Agency has reaffirmed its position that, if the RLD has a dose counter, then the generic will be required to also have a dose counter.  FDA did stop short of requiring all new MDIs to contain a dose counter, and although they said it would be preferable that new MDIs did incorporate such a counter into the design, so the patient would be aware when they are at the end of the useful life of the inhaler- “we (FDA) do not intend at this time to impose a universal requirement that all NDAs for MDI products include an integrated dose counter. We intend to consider the inclusion of an integrated dose counter on a case-by-case basis and in the context of a specific NDA. ”

So the bottom line – MDIs for NDAs will be handled on a case-by-case basis and if you are submitting an ANDA, if the RLD has an integrated dose counter, you will need one to get into the OGD door.  If when the ANDA is submitted, the RLD does not have a dose counter, but obtains approval for such during the pendency of ANDA review, OGD will expect that, prior to approval, the ANDA applicant will amend its application to incorporate a dose counter.