Navigation Links
Perrigo Receives FDA Tentative Approval For Generic Equivalent To Prandin(R)
Date:7/19/2013

ALLEGAN, Mich., July 19, 2013 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for repaglinide tablets, the generic equivalent to Prandin® Tablets (repaglinide tablets).

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

Prandin® tablets (repaglinide tablets), are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of approximately $250 million, as measured by Symphony Health Solutions.

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval shows the talent and expertise of our R&D and regulatory affairs departments. This is another example of Perrigo's commitment to bring new products to market and deliver on its mission to provide quality, affordable healthcare to consumers."

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China 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 30, 2012, 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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Perrigo Company Acquires Ophthalmic Product Portfolio From Fera Pharmaceuticals, LLC For An Upfront Payment Of $93 Million
2. New Breakthroughs Allow Companies to Expand their Reach - Research Report on Perrigo, Auxilium, Actavis, Mylan, and Salix
3. Perrigo Launches First-Ever Industry Marketing Campaign For Store Brand OTC Medications
4. Perrigo Reports Record Revenue and Adjusted Earnings
5. Perrigo Company To Release Third Quarter Fiscal Year 2013 Results On May 7, 2013
6. Perrigo Company To Present At The Barclays Global Healthcare Conference
7. Perrigo Company To Present At The RBC Global Healthcare Conference
8. Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62%
9. Perrigo Company To Present At The Leerink Swann Global Healthcare Conference
10. Perrigo Company Acquires U.K.-based Rosemont Pharmaceuticals Ltd. For Approximately £180 Million Or $283 Million
11. Perrigo Confirms FDA Approval For Testosterone Gel 1%
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... ALBANY, New York , February 5, 2016 /PRNewswire/ ... A new Transparency Market Research report states that the ... bn in 2014 and is predicted to reach US$185.9 ... a CAGR of 6.50% from 2014 to 2020. The ... Market: (Branded/Generic/Over-the-counter, Chemical/Biological, Captive/Contract Manufactured, by Geography, and by ...
(Date:2/5/2016)... England , February 5, 2016 ... --> Today, VoicePower Ltd - The Speech Recognition People, announced ... been deployed to improve patient care, reduce turnaround times and to ... Wirral CCG ,- VoicePower client since 2013 Challenge: ... Challenge: --> - Six doctors ,- Wirral CCG ...
(Date:2/4/2016)... 4, 2016  The Senior Care Pharmacy Coalition ... Committee Chairman Jason Chaffetz (R-UT) and ... hearing , "Developments in the Prescription Drug ... growing questions about abusive pharmacy benefit manager (PBM) ... and Ranking Member Elijah Cummings (D-MD) are diligent, ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... February 06, 2016 , ... Research ... treatment helps to reduce the frequency and level of relapse. , ... Healthy Identity and Purpose,” will explore the critical tasks of the recovery phase ...
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment and retention ... and scientific initiatives have all marked the last 12 months at Roswell Park ... of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined the many ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... H. Van Allen have signed a joint enrollment and degree completion agreement. ... toward associate and baccalaureate degrees at FHU|Dickson. , The agreement allows students ...
(Date:2/5/2016)... Pass, OR (PRWEB) , ... February 05, 2016 , ... ... with modern technology, such water may be safer than regular municipal or well water. ... advocate and radio host Sharon Kleyne, could go a long way toward increasing public ...
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... announced the election of Patrick McDermott as Chairman of the National Board of Directors. ... Pat as Chairman of the Board,” stated Leslie A. Chambers , APDA President ...
Breaking Medicine News(10 mins):