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Executive Summary

GLAXO E-Z-V MDI "NOT INTENDED FOR USE WITH A SPECIFIC DRUG" and therefore the metered-dose inhaler was appropriately cleared for marketing via FDA's 510(k) process, Glaxo argued in a Sept. 13 letter to the agency. Glaxo maintained that the E-Z-V "is an unfilled, separately packaged device that is not intended for use with a specific drug." Therefore, the firm argued, FDA's intercenter agreement on the regulation of combination products "compels the conclusion that the E-Z-V is a medical device subject to the sole review of [the Center for Devices & Radiological Health] and that FDA correctly reviewed and cleared the product via the 510(k) process." Glaxo's letter responds to a petition filed by 3M requesting that FDA revoke Glaxo's November 510(k) clearance for the E-Z-V ("The Pink Sheet" Aug. 23, T&G-8). 3M's arguments in support of the request included the contention that the metered-dose inhaler is a combination product that should be regulated as a drug by the Center for Drug Evaluation & Research under FDA's intercenter agreements. 3M sells a similar MDI, the Autohaler, which is labeled for use with 3M's Maxair. The 3M combo was approved via an NDA. The firm argued that Glaxo's device should be regulated in a similar manner because it is "limited to use" with Glaxo's own drugs, albuterol and beclomethasone. Glaxo says that the E-Z-V does not fit FDA's definition of a combination product requiring drug approval because, although it is intended for use with "certain MDI canisters," it is not intended for use with "specific drug products." Glaxo acknowledged that it is aware of only three currently available drug canisters compatible with the E-Z-V: Glaxo's Ventolin (albuterol) and Beclovent (beclomethasone) and Schering- Plough's Proventil (albuterol). However, "there more E-Z-V-compatible MDI canisters in the future," the letter contends, adding that Glaxo "has no control over other companies' future development and marketing of compatible canisters." Responding to other charges in the 3M petition, Glaxo said that its "intended E-Z-V launch promotion and marketing plan are proper and are fully within the bounds of the 510(k) clearance and the intended use of the device." The E-Z-V promotional materials under development for the Oct. 15 product launch "clearly and prominently [describe] the intended use of the E-Z-V with certain physically compatible MDI canisters." Furthermore, "none of the planned product promotion refers to specific compatible drug products by name or by manufacturer." Glaxo added that it "fully discussed the intended use of E-Z-V and the presently compatible MDI canisters with the CDRH reviewer responsible for the 510(k) submission."

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