Navigation Links
Perrigo Announces FDA Final Approval Of Tris Pharma's Dextromethorphan Polistirex Extended-Release Oral Suspension
Date:5/30/2012

ALLEGAN, Mich., May 30, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that the U.S. Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application (ANDA) for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser's Delsym® suspension. As the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States, Perrigo expects to begin shipping its product during its first fiscal quarter of 2013.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO)

Litigation between Tris and Reckitt Benckiser is ongoing in the United States District Court for the District of New Jersey, where the court has previously granted summary judgment of non-infringement of the asserted patent claims. As the Tris ANDA was the first one submitted with a paragraph IV certification, marketing of the product is entitled to 180 days of generic exclusivity.

Delsym® is indicated for the treatment of cough due to minor throat and bronchial irritation. Perrigo estimates the past 52-weeks sales for the brand were approximately $110 million.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval further highlights our ability to bring new products to our consumers and reinforces our continued focus of making quality healthcare more affordable. We are pleased to add this important new product to our retail and wholesale customers' store brand product portfolios when we begin shipments to them for the upcoming cough/cold/flu season."

Tris Pharma is a technology driven specialty pharmaceutical company which pioneered sustained release in liquid and other unique dosage forms such as chewable/ODT and film strip.

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 Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
2. Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
3. Perrigo Company to Present at the Bank of America Merrill Lynch 2012 Healthcare Conference
4. Perrigo Reports Record Third Quarter Revenue And Earnings And Raises Full Year EPS Guidance
5. Perrigo Company Will Release Third Quarter Fiscal 2012 Results On May 8, 2012
6. Perrigo Company to Present at the RBC Capital Markets Healthcare Conference
7. Perrigo Announces the Launch of Loratadine-D 12 Store Brand Labels -- the First Store Brand Launch That Compares to Claritin-D® 12
8. Perrigo Company to Present at the Leerink Swann 2012 Global Healthcare Conference
9. Perrigo Company Announces Quarterly Dividend
10. Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals
11. Perrigo Wins Summary Judgment in Generic Mucinex® Case
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... Ill. , Feb. 11, 2016  AbbVie, ... the AbbVie Rheumatology Scholarship, designed to provide financial ... disease as they pursue higher education goals. Fifteen ... for the 2016-2017 school year. The AbbVie Rheumatology ... Tracie Haas , vice president, corporate social responsibility, ...
(Date:2/11/2016)... Feb. 11, 2016  Community pharmacists can help improve ... the pharmacy through a custom-built medication synchronization program, Cardinal ... and owner at Schieber Family Pharmacy in ... a lot of patients enrolled in this medication synchronization ... a win for the patient, and it,s a win ...
(Date:2/11/2016)... , Feb. 11, 2016 Scientists from ... method that opens the door to genetic analysis ... have been impossible to isolate with 100 percent ... specific tumor types in various stages of development, ... of these cells that are clinically relevant, and ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... 12, 2016 , ... The Journal of Pain Research has seen ... SJR uses data taken from the Scopus database (Elsevier B.V.) and is a measure ... by the journal over a three year period and also the importance of the ...
(Date:2/11/2016)... ... 11, 2016 , ... The president released a FY 2017 budget request on ... more of the cost burden to military beneficiaries. , MOAA’s president, retired Air ... budget as including limited quantifiable benefit fixes mixed with numerous beneficiary fee hikes. , ...
(Date:2/11/2016)... ... February 11, 2016 , ... Hall Integrative Health and ... for their simultaneous grand openings in March. All seven practices are set to ... wondering, is reversing diabetes possible? According to this 2011 CNN article it is ...
(Date:2/11/2016)... ... 2016 , ... Thermi™, a world leader in thermistor-regulated energy ... promotions of Allison Kelly to executive vice president of the company’s new North ... North American capital sales, and Wendy Oseas to vice president of global marketing. ...
(Date:2/11/2016)... ... 11, 2016 , ... Atlantic Information Services, Inc. (AIS) is ... Case Study for Plans and Purchasers.” Executives from Intel Corp. and Providence Health ... value-based health benefits program Connected Care, will discuss the challenges they faced (and ...
Breaking Medicine News(10 mins):