IMPAX Receives Final FDA Approval For Omeprazole 40 Mg Capsules

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jan 2009 - 2:00 PDT

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IMPAX Laboratories, Inc. (OTC: IPXL), through its generic drug division Global Pharmaceuticals, announced that yesterday the U.S. Food and Drug Administration (FDA) granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Prilosec 40 mg Delayed-release Capsules. AstraZeneca markets Prilosec for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux disease).

The Company's versions of generic Prilosec (including previously approved and marketed 10 mg and 20 mg Capsules) are 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 began marketing the 40 mg product immediately.

According to Wolters Kluwer Health, U.S. sales of Prilosec 40 mg capsules were approximately $222 million in the 12 months ended November 2008.

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: http://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, IMPAX's failure to file any periodic reports subsequent to its quarterly report on Form 10-Q for the quarter ended September 30, 2004, the SEC's revocation of the registration of IMPAX's common stock under section 12 of the Securities Exchange Act of 1934, the actual time that will be required to, file a registration statement on Form 10 with respect to such stock, 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.

IMPAX Laboratories, Inc.

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