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:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American Respiratory ... testing company, is now able to perform sophisticated lung assessments in ... Medical Technologies , Inc. Patients are no longer ... to ndd,s EasyOne PRO ® , ARL patients like Jeanne R. ... testing done in the comfort of her own home. ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
Breaking Medicine Technology:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... for mental health professionals, announced today its affiliation with Tennessee Counseling Association. ... solutions to the network of the Tennessee Counseling Association, adding exclusive benefits and ...
(Date:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
(Date:6/26/2016)... ... 27, 2016 , ... Quality metrics are proliferating in cancer care, and are ... the eye of the beholder, according to experts who offered insights and commentary in ... Managed Care. For the full issue, click here . , For the American ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
Breaking Medicine News(10 mins):