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:2/10/2016)... WOONSOCKET, R.I. , Feb. 10, 2016  CVS ... vaccines to people living in Santa Clara ... of Meningitis B on the Santa Clara University campus. ... vaccines available to protect patients against the disease. Students ... are encouraged to get vaccinated. In addition, anyone who ...
(Date:2/10/2016)... Feb. 10, 2016  Oxis International Inc. (OTC/QB: OXIS) ... was described as a "clinical trial triumph" after one ... into complete cancer remission. Daniel Vallera ... Masonic Cancer Center. --> Daniel Vallera ... Masonic Cancer Center. --> An article ...
(Date:2/10/2016)... 2016  LexisNexis® Risk Solutions, a leading provider ... launch of LexisNexis Provider Performance Monitor , ... and optimize the quality and efficiency of provider ... scores. By measuring provider performance through Provider Performance ... better outcomes, improve the patient experience and reduce ...
Breaking Medicine Technology:
(Date:2/10/2016)... Calif. (PRWEB) , ... February 10, 2016 , ... ... Water Brand. There were three leading bottled water brand owners that topped the list ... that enhance connectivity and optimize conversion. The premier brand was Tibet 5100, a top ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... bring together more than 200 of the country’s top healthcare executives to share ... “The true benefit of the Forum is the provider-centric perspective, experience, expertise and ...
(Date:2/10/2016)... ... ... Armune BioScience signed a definitive agreement with ARCpoint Labs ... country. Launched in April of 2015, Apifiny is the only cancer specific, non-PSA blood ... exceeded 3,000 tests in 2015. Primary care physicians and urologists have utilized Apifiny to ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... the Ohio Safety Congress and Expo event March 9-11, 2016. Hosted by Ohio's ... Convention Center. , As the longest running and largest worker's compensation event ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... Drive, Jacksonville, FL 32224, February 26th: Amateur & Professional Divisions - Time: ... Time: 7:00pm – 10:00pm | Ticket Prices $30, Social Media: http://www.USPoleSportsFed.org ...
Breaking Medicine News(10 mins):