Navigation Links
Perrigo Company Confirms FDA Tentative Approval for Clobetasol Propionate Emulsion Foam
Date:10/6/2011

ALLEGAN, Mich., Oct. 6, 2011 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) announced that it received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05%. Perrigo believes it is first-to-file on this product.

On July 12, 2010, Stiefel Research Australia Pty. Ltd. filed a patent infringement suit in the United States District Court for the District of Delaware to prevent Perrigo from commercializing this product.  This action, which is still pending, formally initiated the process under the Hatch-Waxman Act.

The product is the AB-rated equivalent to Stiefel Laboratories' Olux® -E Foam, 0.05%, a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand were approximately $40 million, according to Wolters Kluwer data for the twelve months ending September 2011.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This tentative approval reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders, it is also another example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business."

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 to Host Analyst Day on October 5, 2011 at the TASE, Tel Aviv Stock Exchange in Tel Aviv, Israel
2. Perrigo to Host Analyst Day on September 27, 2011 at the NASDAQ MarketSite in Times Square
3. Perrigo Announces FDA Final Approval for Ketoconazole Foam, 2%
4. Perrigo Company Will Release Fourth Quarter Fiscal 2011 Results on August 16, 2011
5. Watson Enters into Agreement to Acquire Products Related to Perrigos Acquisition of Paddock Laboratories
6. Perrigo Closes Acquisition of Paddock Labs
7. Perrigo Receives FDA Approval to Market Coated Cinnamon Nicotine Gum
8. Perrigo Provides Update on Acquisition of Paddock Labs
9. Perrigo Announces Launch of the Generic Version of Nasacort® AQ
10. Perrigo Company to Present at the Goldman Sachs 32nd Annual Global Health Care Conference
11. Perrigos Partner Synthon Receives FDA Tentative Approval for Levocetirizine Solution - Generic Equivalent to Xyzal® Oral Solution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... 27, 2016  VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ... whatever measures required to build a strong and stable ... currently listed on the OTC Markets-pink current trading platform. ... CEO, "We are seeing an anomaly in market trading ... only by the Company, but shareholders and market players ...
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 27, 2016 , ... TherapySites, the leading website ... Tennessee Counseling Association. This new relationship allows TherapySites to continue to ... adding exclusive benefits and promotional offers. , "TCA is extremely excited about this ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... technology to revolutionize the emergency ambulance transport experience for the millions of people ... how Uber has disrupted the taxi industry through the use of technology. Now, ...
(Date:6/26/2016)... N.J. (PRWEB) , ... June 27, 2016 , ... Quality ... sources, yet in many ways they remain in the eye of the beholder, according ... (EBO), a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/26/2016)... ... 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to ... app. The fitness app plans to fix the two major problems leading the fitness industry ... fits all type program , They don’t eliminate all the reasons people quit ...
Breaking Medicine News(10 mins):