Navigation Links
Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
Date:5/22/2012

ALLEGAN, Mich., May 22, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1®. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO )

Gynazole·1® (butoconazole nitrate) vaginal cream, 2%, is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). Prior to the voluntary discontinuation of the product in January 2009 due to manufacturing issues at KV Pharmaceutical, Gynazole·1® annual sales were approximately $28 million, as measured by Wolters Kluwer Health.

Perrigo's Chairman, President and Chief Executive Officer, Joseph C. Papa, stated, "This approval once again exemplifies how our robust research and development abilities in the areas of creams, foams, gels and liquids translate into new product approvals. Perrigo is committed to making quality healthcare more accessible and affordable for our customers."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).

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 25, 2011, 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©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
2. Perrigo Company to Present at the Bank of America Merrill Lynch 2012 Healthcare Conference
3. Perrigo Reports Record Third Quarter Revenue And Earnings And Raises Full Year EPS Guidance
4. Perrigo Company Will Release Third Quarter Fiscal 2012 Results On May 8, 2012
5. Perrigo Company to Present at the RBC Capital Markets Healthcare Conference
6. Perrigo Announces the Launch of Loratadine-D 12 Store Brand Labels -- the First Store Brand Launch That Compares to Claritin-D® 12
7. Perrigo Company to Present at the Leerink Swann 2012 Global Healthcare Conference
8. Perrigo Company Announces Quarterly Dividend
9. Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals
10. Perrigo Wins Summary Judgment in Generic Mucinex® Case
11. Perrigo Acquires Assets of CanAm Care for $36 Million
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... 2, 2017  AllianceRx Walgreens Prime, the combined central ... and pharmacy benefit manager Prime Therapeutics LLC (Prime), today ... included the unveiling of new signage at its headquarters ... as at a few other company-owned facilities across the ... patients, some of whom will begin to see the ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation announce a ... sensors for real-time monitoring of patients with trauma-related and ... focused on disruptive health solutions for rare disorders and ... record and integrate behavioral, cognitive, physiological and contextual data. ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... ... 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the ... new design of the shoulder pad. The shoulder pad provides optimal support and ... pain while using cold therapy. By utilizing ice and water that is circulated from ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
Breaking Medicine News(10 mins):