Healthcare Industry News: oxybutynin
News Release - May 9, 2007
IMPAX Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mgMarketing to Begin Immediately
HAYWARD, Calif.--(HSMN NewsFeed)--IMPAX Laboratories, Inc. (OTC: IPXL ; "IMPAX" or "the Company") today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Ditropan® XL, (oxybutynin Chloride) 5 mg and 10 mg Extended-release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. 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 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" statement under the Private Securities Litigation Reform Act 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, 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, 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.
Source: IMPAX Laboratories
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