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:8/27/2020)... FORT MYERS, Fla. (PRWEB) , ... August 27, 2020 , ... ... its Board of Directors. Dr. Friedman is an adult and pediatric neuro-oncologist who serves ... Duke University and as an educator at Duke University Medical School. , Internationally recognized, ...
(Date:8/26/2020)... ... August 26, 2020 , ... ... Services, Laboratory Testing division, expands its technology footprint with the addition of ... platforms available. With industry-leading biomarker solutions, complemented with traditional ligand-binding assays and ...
(Date:8/26/2020)... ... 2020 , ... Crossroads Hospice & Palliative Care Chief Compliance ... her name. , That’s thanks to her completion of two additional certifications this ... Officer (CPCO.) , The CHC is designed to mitigate compliance-related risks. Being ...
Breaking Medicine Technology:
(Date:8/31/2020)... ... ... out your dear friend has cancer? , It’s hard to hear your doctor say the ... Once the shock wears off, the questions and fears can be overwhelming. , How should ... help? Words are failing me. I’m scared. I want to DO something. , We’ve talked ...
(Date:8/31/2020)... ... 31, 2020 , ... Smile Brands Inc., one of the ... States, today announced the grand opening of another affiliated Bright Now! Dental ... convenient hours, a comfortable office, and full-service care at the new Beaumont location. ...
(Date:8/31/2020)... ... August 31, 2020 , ... Bonde Innovations, LLC, a venture-backed ... heart failure, today announced that the company has been awarded a Phase 1 ... National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH). ...
(Date:8/28/2020)... DOWNERS GROVE, Ill. (PRWEB) , ... August 28, ... ... to COVID-19, The Nourished Group set out to continue helping the ... , attendees can discover new gluten-free products, get coupons, enter giveaways, chat with ...
(Date:8/27/2020)... (PRWEB) , ... August 27, 2020 , ... ... doors! Sikara Medspa is a leading aesthetic and wellness retreat. The practice is ... and surrounding areas of Las Vegas. , Designed to be a sanctuary ...
Breaking Medicine News(10 mins):