New FDA citizen’s petition

On May 4, 2015, a citizen’s petition was filed by 3M Drug Delivery Systems (“3M”) with the FDA asking that the Commissioner refrain from approving any ANDA or 505(b)(2) application, unless certain labeling conditions are met.  In particular, 3M requests that the FDA require all ANDA and 505(b)(2) applications for albuterol sulfate metered dose inhalers to contain an actuator that is either embossed or labeled to indicate its use with the accompanying canister.

By:  Jacqueline A. DiRamio

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