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:10/12/2017)... Oct. 12, 2017   Divoti USA will ... to the standard of the latest FDA requirements, which stipulates new ... Anyone in need of Medical ID jewelry such as Medical ... are engraved in terms of the new FDA requirements ... Divoti offers this dark ...
(Date:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
(Date:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one ... an innovative new design of the shoulder pad. The shoulder pad provides optimal ... controlling your pain while using cold therapy. By utilizing ice and water that is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. ... recently contributed a medical article to the newly revamped Cosmetic Town journal ... spotlights the hair transplant procedure known as Follicular Unit Extraction (FUE). ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s National ... 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. ... for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., ...
Breaking Medicine News(10 mins):