Navigation Links
Perrigo Company Receives Final Approval on Clobetasol Propionate Foam
Date:3/11/2008

Court Issues Temporary Restraining Order

ALLEGAN, Mich., March 11 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.

The product is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R) Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008. As the first filer, Perrigo will be eligible for 180 days of generic marketing exclusivity once it launches the product.

Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviously excited about this approval. This approval reflects our on-going efforts to make quality healthcare more affordable for our customers and drive value for our shareholders."

In late 2005, Connetics Corporation, which sells the brand drug, filed a patent infringement suit against Perrigo in the United States District Court for the District of New Jersey following Perrigo's paragraph IV patent certification in its ANDA stating that the Connetics' patent is invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In response to a motion filed by Connetics last Thursday, the Court temporarily restrained Perrigo, as of March 7, 2008, from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19, 2008. On that date, the Court will hear arguments on Perrigo's pending Summary Judgment Motion as well as Connetics' Motion for a Preliminary Injunction.

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. 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 manufacturing facilities are the United States, Israel, Mexico and the United Kingdom. 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, 2007, 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©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Perrigo Company to Market Over-the-Counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets
2. Perrigo Company Announces Initial Shipments of Store Brand Omeprazole Tablets
3. Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewable Tablets
4. Perrigo Company Authorizes Continuation of Share Repurchase Program and Announces Quarterly Dividend
5. Perrigo Acquires UK OTC Store Brand Supplier
6. Perrigo Company to Present at The 26th Annual JPMorgan Healthcare Conference
7. Perrigo Announces that Dexcels Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
8. Perrigo Company Announces Dividend Increase
9. Perrigo Company Will Release First Quarter Fiscal 2008 Results on November 1, 2007
10. Perrigo Confirms Filing for Generic Version of Mucinex(R) and Announcement of Lawsuit by Adams Respiratory
11. Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/6/2016)... ... February 06, 2016 , ... ... EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , WHAT:     , This conference ... estimated 5000 perioperative nurses in attendance to study the latest evidence-based recommendations ...
(Date:2/6/2016)... ... ... Shark Finds and Kevin Harrington, along with the Product Managers ... Belly Bands. , Having a dog is great—except when it wets every couch, bed, ... works, get Belly Bands, the easiest way to stop dogs from wetting on ...
(Date:2/5/2016)... NY (PRWEB) , ... February 05, 2016 , ... Love ... long-stem roses in a variety of colors, assortments and packaging. This staple for Valentine’s ... any King Kullen location. , For Valentine’s Day, not only are long-stem roses ...
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment ... new clinical and scientific initiatives have all marked the last 12 months at ... and CEO of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco Canales, MD and ... their Napa Valley office. The technique utilizes the body’s own healing abilities to ... Dr. Furnas, are part of only a select few cosmetic surgeons bringing this ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... , Feb. 4, 2016   Bernstein Liebhard LLP ... filed in the United States District Court for the District ... class (the "Class") consisting of all persons or entities who ... "Company") (NASDAQ: INSY ) from March 3, 2015 through ... and certain of its officers with violations of the Securities ...
(Date:2/4/2016)... Feb. 4, 2016 Summary Breast cancer, ... and the most common cancer in women worldwide, accounting ... exceedingly prevalent. The number of women diagnosed with breast ... the number of deaths has declined due to earlier ... has been revolutionized in the past four decades, especially ...
(Date:2/4/2016)... Feb. 4, 2016 Mettler-Toledo International Inc. (NYSE: ... 2015.  Provided below are the highlights: , ... compared with the prior year.  Reported sales decreased 3% ... quarter. , Net earnings per diluted share as ... prior- year period.  Adjusted EPS was $4.65, an increase ...
Breaking Medicine Technology: