Navigation Links
Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals
Date:1/23/2012

ALLEGAN, Mich., Jan. 23, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories, Inc. (Nasdaq: IPXL), who will share costs and benefits of this project.

On January 19, 2012, Meda Pharmaceuticals filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. 

Astepro® Nasal Spray is a prescription medicine for people 12 years of age and older and is approved to treat nasal symptoms caused by seasonal allergies or environmental irritants. Annual sales were approximately $114 million annually, as measured by Wolters Kluwer Health.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to partner with Impax on this important product opportunity. As always, Perrigo is committed to making quality healthcare more affordable for our customers."          

Impax's President and CEO Larry Hsu, P.h.D. stated, "We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base."

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 Wins Summary Judgment in Generic Mucinex® Case
2. Perrigo Acquires Assets of CanAm Care for $36 Million
3. Perrigo Company to Present at the 30th Annual J.P. Morgan Healthcare Conference
4. Zacks Industry Outlook Highlights: Vertex Pharma, Human Genome Sciences, Biogen Idec and Perrigo
5. Perrigo Announces FDA Final Approval for Desloratadine
6. Perrigo Expands Infant Formula Distribution in China With Brilite Nutritionals (Shanghai) Co., Ltd.
7. Perrigo and its Partner Synthon Launch Levocetirizine Solution - Generic Equivalent to Xyzal® Oral Solution
8. Perrigo Confirms Filing for Testosterone Gel 1.0% and Announcement of Patent Infringement Lawsuit by Abbott
9. Perrigo Announces Launch of Generic Version of Elestat®
10. Perrigo Company to Attend the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology
11. Perrigo Reports Record Quarterly Revenue and Adjusted Earnings and Raises Full Year Adjusted EPS Guidance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... OTTAWA, Ontario , June 27, 2016  VMS ... the Company,s Board will take whatever measures required to ... the Company,s stock which is currently listed on the ... S Wexler, Company Chairman and CEO, "We are seeing ... be difficult to understand, not only by the Company, ...
(Date:6/24/2016)... June 24, 2016  Collagen Matrix, Inc., ("Collagen ... and manufacturing of collagen and mineral based medical ... that Bill Messer has joined the ... further leverage the growing portfolio of oral surgery, ... Bill joins the Collagen Matrix executive team ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
Breaking Medicine Technology:
(Date:6/26/2016)... Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in ... in honor of the city’s history as home to some of the world’s leading ...
(Date:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
Breaking Medicine News(10 mins):