3M: Integrated Dose by Dose Counter Receives FDA Approval
The FDA has granted approval to a new inhalation product utilizing the 3M Integrated Dose by Dose Counter. The product, which also incorporates 3M’s Fluorinated Ethylene Polymer (FEP) coating, received FDA approval after a one-cycle review of the New Drug Application.
The Integrated Dose by Dose Counter helps prevent patients from running out of medication in their metered-dose inhalers by providing an accurate count of how much medication remains. The device is displacement driven and utilizes a novel split-count design that matches dose counter actuation as closely as possible to valve travel to prevent under-counting and to minimize the potential for over-counting due to misuse. The counter utilized global patient research during development, resulting in a device that is easy for patients to use, requiring no additional training, and that retains a familiar look and feel.
The 3M Integrated Dose by Dose Counter is compatible with most valves and customizable to meet partners’ requirements. An additional component of the newly approved product, the FEP coated canister, helps reduce drug deposition to improve chemical and physical stability. Whether formulated as a suspension or solution, the active pharmaceutical ingredients (API) in pressurized metered-dose inhalers can interact with the container closure system. The FEP coating, however, helps prevent deposition of the API on canister walls and reduces canister-formulation interactions.
The approval of this new product following a one-cycle review is a testament to the quality of our dose counter and FEP coating, as well as a demonstration of our expertise in regulatory documentation,” said Robert Odenthal, Vice President of Respiratory Business. “3M is pleased to help bring this product to market successfully.