Impax Laboratories, Inc. (IPXL), along with TOLMAR, Inc., announced Wednesday that the U.S. Food and Drug Administration or FDA has granted final approval for the generic version of Solaraze Gel (diclofenac sodium-3%).
TOLMAR was the first company to file a substantially complete Abbreviated New Drug Application or ANDA for the generic version of Solaraze Gel containing a Paragraph IV certification.
Impax said its generics division, Global Pharmaceuticals, intends to commercialize this first-to-file product shortly. The last Orange Book listed patent expires August 11, 2015.
Under the Development, Supply and Distribution Agreement with TOLMAR entered in 2012 June, Impax was granted an exclusive license to commercialize generic Solaraze in the United States and its territories. Under the terms of that deal, TOLMAR is responsible for developing and manufacturing the product, and Impax is responsible for the marketing and sale of the product.
According to IMS Health, U.S. sales of Solaraze Gel 3% were approximately $78 million for the 12 months ended September 2013.
Solaraze is from PharmaDerm, a Division of Fougera Pharmaceuticals Inc.
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