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IMPAX Laboratories, Inc. (IPXL) and TOLMAR Inc. Announce Final FDA Approval for Generic Solaraze® Gel (Diclofenac Sodium-3%)



10/30/2013 7:38:51 AM

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HAYWARD, Calif. & FORT COLLINS, Colo.--(BUSINESS WIRE)--Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of TOLMAR’s Abbreviated New Drug Application (ANDA) for its generic version of Solaraze® Gel (diclofenac sodium-3%). 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.

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