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:11/29/2015)... ... , ... Key Housing, a top-rated corporate housing service for the San Jose ... Epic. In showcasing this featured apartment community in San Jose, Key Housing is helping ... efficiently find housing suitable to their needs by showcasing quality housing. , “San Jose ...
(Date:11/28/2015)... ... November 28, 2015 , ... Trying to relax on a ... COUCH BUDDY. "I conceived of this design due to personal experience with a bad ... It promotes relaxation and convenience, as well as increases support. It also makes it ...
(Date:11/27/2015)... ... ... There is only one major question facing all law firms in the ... has not been an easy question to answer. Especially when the senior partners and ... don’t share the same discipline around working long hours. , In addition to ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article ... the way that they are handling security in light of the recent terrorist attacks ... in an attempt to stop an attack from reaching U.S. soil. Especially around special ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... a safe and convenient way to dispense prescription medications at home, so he ... effective way to monitor and dispense prescription medications. In doing so, it could ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... -- Research and Markets ( ) has announced ... by Type (Dressings, Therapy Devices, Active Wound Care), Application ... and Geography - Global Forecast to 2020" report ... --> The purpose of this report is ... global advanced wound care market. It involves deep dive ...
(Date:11/26/2015)... , November 26, 2015 ... --> adds "Global Repaglinide ... "Investigation Report on China Repaglinide Market, ... forecasts data and information to its ... . --> ...
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Italian therapeutic drug monitoring market, ...
Breaking Medicine Technology: