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:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical ... innovative solutions for injectable drug administration, today shared the ... ID Adapter for improving the intradermal administration of polio ... Skin Vaccination Summit in May 2017 by Dr. ... Polio Department, World Health Organization (WHO), and recently published ...
(Date:10/4/2017)... , Oct. 4, 2017 OBP ... self-contained, illuminating medical devices, today announced regulatory approval ... Surveillance Agency (or Agência Nacional de Vigilância Sanitária ... single-use, cordless surgical retractor with integrated LED light ... access, illumination and exposure of a tissue pocket ...
(Date:10/2/2017)... The Rebound mobile app is poised to become ... tide of prescription drug addiction. The app empowers users to ... stepping down their dosage in a safe, controlled manner while ... the first 100,000 people to sign up will enjoy 3 ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... As health professionals work to improve ... engagement.” The patient is doing more than filling out a survey; in many cases ... an increasing emphasis in health care and research on the importance of active engagement ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International ... promote standards of excellence for the field of eating disorders, announces the opening ... 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... QUEENS, N.Y (PRWEB) , ... October 13, 2017 , ... ... recently became a member of ElderCounsel, a national organization of elder law and special ... constantly changing laws and rules. It also provides a forum to network with elder ...
(Date:10/13/2017)... ... , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to ... unique items from across the nation, this holiday-themed event will raise funds and awareness ... VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Yisrayl Hawkins, ... week that explains one of the most popular and least understood books in the ... cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed it ...
Breaking Medicine News(10 mins):