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:9/6/2017)... 2017 Eli Lilly and Company (NYSE: ... data for galcanezumab and lasmiditan, two investigational treatments for ... Society (IHC) taking place Sept. 7-10 in ... new, long-term data from an open-label study evaluating the ... mg and 240 mg) for the prevention of migraine. ...
(Date:9/5/2017)... , Sept. 5, 2017 Oramed Pharmaceuticals Inc. ... ), a clinical-stage pharmaceutical company focused on the development ... has successfully concluded its meeting with the U.S. Food ... oral insulin formulation. ... the regulatory pathway for submission of ORMD-0801, would be ...
(Date:8/29/2017)... Va. , Aug. 29, 2017 ivWatch, LLC, the ... peripheral IV infiltrations, announced it has been awarded an Innovative Technology ... company in the country. ... continuous monitoring device to aid in the early detection of peripheral ... The Innovative ...
Breaking Medicine Technology:
(Date:9/24/2017)... Providenciales, Turks & Caicos Islands, BWI (PRWEB) , ... September 24, ... ... Caicos Islands, the #1 rated resort on TripAdvisor and one of Provo's premier boutique ... was no reported structural damage to the resort after devastating Hurricanes Irma and more ...
(Date:9/24/2017)... ... ... I”, a young boy was walking home and feeling down about himself. He didn’t think ... new friend says he can do whatever he wants to do if he puts his mind ... he is. God created him with special talents and gifts. We see his internal dialogue ...
(Date:9/23/2017)... ... September 23, 2017 , ... ... to fighting obesity of Robert Kushner, director of Chicago’s Center for Lifestyle Medicine ... promoting healthier habits, the article notes that the center routinely recommends weight loss ...
(Date:9/22/2017)... ... 2017 , ... MEDIA OPPORTUNITY: , Save Our Hospital - Albert Lea will ... are rallying against Mayo Clinic. Specifically, media can talk to steering committee members and ... to close the Albert Lea hospital. , The rally aims to protect the most ...
(Date:9/22/2017)... ... 2017 , ... Fenwick Agency of Plano, TX has announced the commencement of ... the nationally recognized ‘Agents of Change’ movement. The agency pledges to select a new ... seek out those who most need help. Their hope is to bring awareness to ...
Breaking Medicine News(10 mins):