IMPAX Receives Final FDA Approval For Generic SOLODYN Extended-Release Tablets, 45mg, 90mg And 135mg

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 08 Feb 2009 - 1:00 PDT

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IMPAX Laboratories, Inc. (OTC: IPXL) confirmed 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 SOLODYN(R) (minocycline HCI) 45mg, 90mg and 135mg Extended-release Tablets. Medicis markets SOLODYN(R) for the treatment of moderate-to-severe acne.

As previously announced on December 1, 2008, IMPAX and Medicis entered into a Settlement and License Agreement, under which IMPAX has a license to market its generic versions of SOLODYN(R) 45mg, 90mg and 135mg through Global Pharmaceuticals, IMPAX's generic division, under the SOLODYN(R) intellectual property rights belonging to Medicis, no later than November 2011. Upon launch of its generic formulations of SOLODYN(R), IMPAX may be required to pay Medicis a royalty, based on sales of those generic formulations by IMPAX under terms described in the Settlement and License Agreement.

According to Wolters Kluwer Health, U.S. sales of SOLODYN(R) were approximately $340 million across all strengths for the 12 month period ending December 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, 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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