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:10/10/2017)... Pa. , Oct. 10, 2017   West ... in innovative solutions for injectable drug administration, today shared ... West,s ID Adapter for improving the intradermal administration of ... Fourth Skin Vaccination Summit in May 2017 by Dr. ... Lead, Polio Department, World Health Organization (WHO), and recently ...
(Date:10/4/2017)... South Korea , Oct. 4, 2017  South ... its next-generation CPR training aide "cprCUBE" on Kickstarter. The ... chest compression during cardiac arrests with better efficiency compared ... It also offers real-time feedback on efficacy of the ... The crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... The International Association of Eating Disorders ... for the field of eating disorders, announces the opening of early registration for ... Florida at the Omni Resort at ChampionsGate. , The annual iaedp™ ...
(Date:10/13/2017)... N.Y (PRWEB) , ... October 13, 2017 , ... Lori ... became a member of ElderCounsel, a national organization of elder law and special needs ... changing laws and rules. It also provides a forum to network with elder law ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
Breaking Medicine News(10 mins):