Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

GLAXO E-Z-V MDI "NOT INTENDED FOR USE WITH A SPECIFIC DRUG"

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 may...be 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."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1133833

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel