Navigation Links
Perrigo Announces FDA Final Approval for Desloratadine
Date:12/27/2011

ALLEGAN, Mich., Dec. 27, 2011 /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 Desloratadine tablets (5 mg).  Perrigo had been sued for patent infringement based upon its filing of an ANDA containing a Paragraph IV certification and settled the case in 2008. Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter (OTC) product depending on its status at the time of launch. 

This product is an AB-rating as equivalent to Schering-Plough's Clarinex® tablets (5 mg) indicated for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. Sales for the brand were approximately $185 million, according to Wolters Kluwer data.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's continued commitment to bring new products to the market. Perrigo continues to be focused on our mission of making quality healthcare more affordable for consumers."

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 Approval for Over-the-Counter Childrens Cetirizine Oral Solution
2. Perrigo and Partner Cobrek Confirms Filing for Generic Version of Evoclin(R) and Announcement of Lawsuit by Stiefel
3. Perrigo Announces FDA Final Approval for Polyethylene Glycol 3350
4. Perrigo Confirms Filing for Generic Version of Mens Rogaine(R) Foam
5. Perrigo Company Will Release First Quarter Fiscal 2010 Results on November 2, 2009
6. Perrigo Company Announces Dividend Increase
7. Perrigo Company Announces Quarterly Dividend
8. Perrigo Company Will Release Second Quarter Fiscal 2010 Results on February 2, 2010
9. Perrigo Company to Present at the 28th Annual J.P. Morgan Healthcare Conference
10. Perrigo Company To Present at the Sidoti Emerging Growth Conference
11. Perrigo Confirms Filing for Generic Version of Clobex(R) Spray and Announcement of Lawsuit by Galderma and Dermalogix
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... , April 24, 2017 SW Safety Solutions, ... and comfort, announces the release of the latest advancement ... most recent example of leading edge nitrile glove technology ... for 200% more tactile grip on wet and oily ... durability. With TracTek and a suite of other advanced ...
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... -- Research and Markets has announced the ... Prospects: Addressing Production Complexities Through Risk Management and Quality ... ... and Market Prospects: Overcoming Production Complexities Through Risk Management ... the current trends in the global biosimilars market, with ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Somnoware, a leading ... Word(TM) Online(TM), which enables sleep physicians to create and edit their interpretation reports. ... and provides a familiar interface that does not require additional training to use. ...
(Date:4/28/2017)... ... April 28, 2017 , ... Horizon Blue Cross Blue ... company’s credit rating of “A” and its outlook as “stable.” At the same time, ... which have fallen in recent years, dip below “capital adequacy” thresholds required for its ...
(Date:4/28/2017)... NY (PRWEB) , ... April 28, 2017 , ... ... Laboratory to expanded distribution of the GlycoMark test throughout the Northeast U.S. ... hyperglycemia in patients with diabetes. The GlycoMark test provides a clinically proven one- ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... ... Direct Replace tubes . These lamps offer an instant energy-saving solution for F32T8 ... to rewire fixtures or disconnect ballasts. These 50,000 hour rated lamps utilize the ...
(Date:4/28/2017)... york (PRWEB) , ... April 28, 2017 , ... ... to announce that Aditya Patel M.D. has joined the revolutionary endoscopic practice under ... and board certification in Interventional Pain Medicine. The patented, revolutionary eDiscSculpt Technique created ...
Breaking Medicine News(10 mins):