Navigation Links
Matrixx Initiatives, Inc. Received a Warning Letter From the Food and Drug Administration
Date:6/16/2009

SCOTTSDALE, Ariz., June 16 /PRNewswire-FirstCall/ -- Matrixx Initiatives, Inc. (Nasdaq: MTXX), today received a Warning Letter from the Food and Drug Administration (the "FDA"). The FDA has asserted that the Company is in violation of its regulations by failing to file a new drug application for its Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs and that those products are misbranded under their regulations for failing to adequately warn of risks. The FDA referred to numerous complaints it has received of anosmia associated with the use of these products.

The Company believes these products are safe and do not cause anosmia. The Company's position is supported by the cumulative science and has been confirmed by a multi-disciplinary panel of scientists. (See the Company's Report on Form 10-K under the heading "Legal Proceedings - Product Liability Matters" for additional information.)

The Company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace. These products constituted approximately 40% of the Company's net sales in 2009.

About Matrixx Initiatives, Inc.

Matrixx Initiatives, Inc. is engaged in the development and marketing of over-the-counter healthcare products that utilize innovative drug delivery systems. Zicam, LLC, its wholly-owned subsidiary, markets and sells Zicam(R) products in the cough and cold category. For more information regarding Matrixx products, go to www.Zicam.com. To find out more about Matrixx Initiatives, Inc. (Nasdaq: MTXX), visit our website at www.matrixxinc.com. For additional information, contact William Hemelt, Acting President and Chief Operating Officer, 602-385-8888, or Bill Barba, Treasurer, at 602-385-8881. Matrixx is located at 8515 E. Anderson Dr., Scottsdale, Arizona 85255.

Matrixx Initiatives, Inc. Forward-Looking Statement Disclaimer:

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "plan," "anticipate," and other similar statements of expectation identify forward-looking statements and include statements regarding response to the Food and Drug Administration. These forward-looking statements are based on the Company's current expectations and are subject to a number of risks and uncertainties, many of which cannot be predicted or quantified and are beyond the Company's control. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. Factors that could cause actual results to differ materially from the Company's expectations include: (a) the severity and timing of the cold season; (b) the possibility that future sales of our products will not be as strong as expected; (c) the possibility that supply issues may impact future sales of our products; (d) the possibility that our products may face increased competition or negative publicity; (e) the potential impact of current and future product liability litigation; (f) regulatory issues including requirements by the FDA or public relations challenges; (g) the possibility of delays or other difficulties in selling our products in Canada or in implementing new product improvements and introducing to the marketplace new products and brands; (h) and the possibility that expenses, including legal expenses, product reserves, and expenses associated with adverse litigation outcomes or the voluntary product recall, may exceed expected amounts. Other factors that could cause actual results to differ materially from the Company's expectations are described in the Company's Annual Report on Form 10-K filed on June 8, 2009, under the heading "Risk Factors," filed pursuant to the Securities Exchange Act of 1934. We do not undertake, and we specifically disclaim, any obligation to publicly update or revise any forward-looking statement whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Matrixx Initiatives, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Matrixx Initiatives, Inc. to Present at the Roth Capital Partners 2007 New York Conference
2. Matrixx Initiatives, Inc. to Present at the William Blair & Company Small-Cap Growth Stock Conference
3. Matrixx Initiatives, Inc. Updates 2007/2008 Cold Season Trends and Fiscal 2008 Sales and Earnings Outlook
4. Matrixx Initiatives, Inc. Sets Time for Discussion of Third Quarter Fiscal 2008 Financial Results
5. Matrixx Initiatives, Inc. Reports Fiscal 3rd Quarter Net Sales of $30.8 Million and Net Loss of ($0.07) Per Share
6. Matrixx Initiatives, Inc. to Present at the Roth Capital Partners 20th Annual OC Growth Stock Conference
7. Rising Medical Solutions Partners With myMatrixx to Deliver Integrated Pharmacy Management Solutions
8. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2008 Financial Results
9. Matrixx Initiatives, Inc. Announces Fiscal 2008 Revenue of $101 Million and Net Income Growth of 59% to $10.4 Million, or $1.04 Earnings Per Share Versus $0.66 in the Prior Year
10. Matrixx Initiatives Selects GolinHarris as Agency of Record for Zicam Brand
11. Matrixx Initiatives, Inc. Sets Time for Discussion of Third Quarter Fiscal 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology: