Navigation Links
Perrigo Confirms Patent Challenge of Monistat(R) 1 Combination Pack

ALLEGAN, Mich., April 21 /PRNewswire-FirstCall/ .- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream, 2% and Suppository, 1.2g, a generic version of Monistat(R) 1 Combination Pack. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against Monistat 1.

Monistat 1 Combination Pack (miconazole nitrate vaginal cream, 2% and suppository, 1.2g) is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc.

Perrigo filed its ANDA for Miconazole Nitrate Vaginal Cream, 2% and Suppository 1.2g containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified Johnson & Johnson, the New Drug Application holder for Monistat 1 Combination Pack, and McNeil-PPC, Inc., the listed patent owner, of its filing. On April 18, 2008, McNeil filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act.

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet ( ).

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 30, 2007, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Perrigo Company
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Perrigo Vice Chair Mori Arkin To Retire After 30 Years of Service
2. Perrigo Company to Host Analyst Meeting on September 18, 2007
3. Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution
4. Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution
5. Perrigo Confirms Filing for Generic Version of Mucinex(R) and Announcement of Lawsuit by Adams Respiratory
6. Perrigo Company Will Release First Quarter Fiscal 2008 Results on November 1, 2007
7. Perrigo Company Announces Dividend Increase
8. Perrigo Announces that Dexcels Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
9. Perrigo Company to Present at The 26th Annual JPMorgan Healthcare Conference
10. Perrigo Acquires UK OTC Store Brand Supplier
11. Perrigo Company Authorizes Continuation of Share Repurchase Program and Announces Quarterly Dividend
Post Your Comments:
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... philanthropic seniors, is resulting in a way for homeless people to have a ... have launched a new initiative whereby they are repurposing plastic bags into sleeping ...
(Date:11/25/2015)... ... November 25, 2015 , ... Since its launch in ... involving adult stem cell therapies to patients with chronic degenerative medical conditions. Now, ... a Registered Trademark (RTM). , Organizations are required to hold a registered trademark ...
(Date:11/24/2015)... ... November 25, 2015 , ... Genesis Chiropractic Software helps practice ... an agreement between the practice owner and the patient that automatically manages all ... projections. Click here to learn more. , According to ...
(Date:11/24/2015)... , ... November 24, 2015 , ... New patients who ... a referral for dental implants at her Mississauga, ON practice. Dr. Williams ... in the placement of dental implants. , Missing teeth can lead to a ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , Nov. 24, 2015  DILON Diagnostics and ... signed an agreement for DILON to distribute GE,s Discovery ... the globe. The signing of this distribution agreement will provide ... Molecular Breast Imaging system and is considered an initial ... better healthcare solutions for clinicians and their patients. ...
(Date:11/24/2015)... 24, 2015 . ... adds Latest Guidebook for Chinese Medical Device ... published in November 2015 to the medical devices ... library at . ... growing global economies with a fifth population in ...
(Date:11/24/2015)... -- Figure 1, a free mobile-first network that enables healthcare ... a new completely redesigned web version that includes uploading. ... work primarily on a desktop, to upload images directly ... user base, Figure 1 is hosting an event during ... (RSNA) Annual Meeting. Joshua Landy ...
Breaking Medicine Technology: