logo
Share SHARE
FONT-SIZE Plus   Neg

Impax Laboratories, TOLMAR Announce Final FDA Approval For Generic Solaraze Gel

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Low-cost airline Allegiant Air announced its order for brand-new aircraft for the first time in its history. The carrier announced on Friday it had reached a deal to purchase 12 current-generation models of Airbus' A320 narrow-body jets. The company termed the deal as "another step towards Allegiant's... Los Angeles City officials have filed criminal charges against Soylent CEO Robert Rhinehart for placing a bright red shipping container on Montecito Heights hillside as part of his "experiment in sustainable living." City Attorney Mike Feuer Friday announced that his office has filed multiple criminal... A new study says that if Hillary Clinton is elected then her proposals will strengthen the U.S. economy and create millions of jobs. According to Moody's Analytics, Hillary Clinton's economic proposal would oversee a "somewhat stronger U.S. economy." The conclusion was reached after assessing her...
comments powered by Disqus
Follow RTT