Healthcare Industry News: Bayer HealthCare Pharmaceuticals
News Release - May 19, 2009
Impax Receives FDA Approval for Generic Precose Tablets, 25 mg, 50 mg and 100 mgHAYWARD, Calif.--(HSMN NewsFeed)--Impax Laboratories, Inc. (NASDAQ: IPXL ) today confirmed that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for generic versions of Precose® Tablets (acarbose), 25 mg, 50 mg and 100 mg strengths. Precose®, a Bayer HealthCare Pharmaceuticals product, is used in the management of type two diabetes mellitus.
The Company expects to launch all strengths in the fourth quarter of 2009, through Global Pharmaceuticals, Impax’s generic division.
According to Wolters Kluwer Health, U.S. generic and brand sales for Acarbose 25 mg, 50 mg and 100 mg tablets were approximately $32 million for the 12 months ended March 2009.
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; ability to timely file periodic reports required by the Exchange Act; ability to maintain an effective system of internal control over financial reporting; ability to sustain profitability and positive cash flows; ability to maintain sufficient capital to fund operations; any delays or unanticipated expenses in connection with the construction of our Taiwan facility; ability to successfully develop and commercialize pharmaceutical products; the uncertainty of patent litigation; consumer acceptance and demand for new pharmaceutical products; the impact of competitive products and pricing; the difficulty of predicting Food and Drug Administration (“FDA”) filings and approvals; inexperience in conducting clinical trials and submitting new drug applications; reliance on key alliance agreements; the availability of raw materials; the regulatory environment; exposure to product liability claims; fluctuations in operating results and other risks detailed from time to time in our 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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