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Impax, TOLMAR announce generic Solaraze Gel final FDA approval

Impax Laboratories and TOLMAR announced that the U.S. Food and Drug Administration has granted final approval of TOLMAR’s Abbreviated New Drug Application for its generic version of Solaraze Gel. TOLMAR was the first company to file a substantially complete ANDA containing a Paragraph IV certification, and Impax’s generics division, Global Pharmaceuticals, intends to commercialize this first-to-file product shortly. The last Orange Book listed patent expires August 11, 2015.