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news.Impax Laboratories, a technology-based specialty pharmaceutical company, has confirmed that the FDA has granted final approval of the company's abbreviated new drug application for generic versions of Solodyn 45mg, 90mg and 135mg extended-release tablets.
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Medicis markets Solodyn for the treatment of moderate-to-severe acne. Impax and Medicis have previously entered into a settlement and license agreement, under which Impax has a license to market its generic versions of Solodyn 45mg, 90mg and 135mg through Global Pharmaceuticals, Impax’s generic division, under the Solodyn intellectual property rights belonging to Medicis, no later than November 2011.
Upon launch of its generic formulations of Solodyn, 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.
Impax Laboratories is a technology based specialty pharmaceutical company, which applys 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 and it has developed marketing partnerships to fully leverage its technology platform.