Printer Friendly
The Free Library
14,716,107 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

IMPAX Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mg.


-Marketing to Begin Immediately-

HAYWARD, Calif. -- IMPAX Laboratories, Inc. (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
: IPXL) ("IMPAX" or "the Company") today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted final approval of the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA ANDA
abbr.
abbreviated new drug application
) for generic versions of Ditropan[R] XL, (Oxybutynin Chloride ox·y·bu·ty·nin chloride
n.
An anticholinergic drug used to treat incontinence and other urinary symptoms.


oxybutynin chloride (ok´sēbū´tinin klor´īd), 
) 5 mg and 10 mg Extended-release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence Urinary Incontinence Definition

Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it.
. U.S. sales of both the branded and generic 5 mg and 10 mg dosage forms were approximately $233 million in the 12 months ended March 2007, according to Wolters Kluwer Health.

The Company's version of generic Ditropan XL is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd. (Nasdaq: TEVA). Teva plans to begin marketing the product immediately.

"This is our second FDA approval this year and we look forward to working with our partner on the launch of our generic version of 5 mg and 10 mg Ditropan XL," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer. "We are pleased to add these dosage forms to our 15 mg version, which received approval and 180-day marketing exclusivity last November," Dr. Hsu added.

About IMPAX Laboratories, Inc.

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX's stock, the SEC proceeding to determine whether to suspend or revoke the registration of IMPAX's securities under section 12 of the Securities Exchange Act, IMPAX's delay in filing its 2004 Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
, its Form 10-Q for each of the first three quarters of 2005, its Form 10-K for 2005, its Form 10-Q for each of the first three quarters of 2006, and its Form 10-K for 2006, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:May 9, 2007
Words:622
Previous Article:SAS Positioned in Leaders Quadrant for Customer Data Mining Magic Quadrant.
Next Article:News From USW: Unions Form Global Network for Kimberly-Clark Workers.
Topics:



Related Articles
FDA APPROVES BIOVAIL'S GENERIC PROCARDIA XL 30MG DOSAGE.
Teva Announces Novartis' Sandoz Unit Seeks to Delay First FDA Approval of Generic Zocor(R).
FDA APPROVES TEVA'S ANDA TO MARKET GENERIC VERSION OF ZOCOR.
IMPAX Receives FDA Approval for Generic Versions of Urecholine(R) Tablets.
IMPAX Receives Final FDA Approval and First-to-File Status for Generic Version of Ditropan(R) XL 15 mg.
Anchen Announces Approval of Generic Version of Wellbutrin XL(R).
IMPAX Announces FDA Approval of Generic Wellbutrin XL 300 mg.
Boca Pharmacal Receives FDA Approval for Generic Version of Panlor(R)SS.
NEUROMED LICENSES PHASE 3 CHRONIC PAIN PRODUCT FROM ALZA.
IMPAX Receives Final FDA Approval for Generic Xanax(R) XR Extended Release Tablets.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles