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
They say there's plenty of fish in the sea, but very few of them are as wealthy as these tycoons. May be they have been so busy building their empires they never had the time to stick with a perfect partner to build their family. This list of the richest singles is assorted — from a 34 year-old... Anthony Levandowski, the head of Uber's self-driving division, is stepping away from his role as Uber continues a legal battle with Waymo, Levandowski's former employer. Levandowski, who founded startup Otto, became head of Uber's Advanced Technologies Group or ATG after Otto was acquired by Uber in August 2016. Southwest Airlines Co. has decided to end the practice of overbooking flights, the airline's CEO Gary Kelly said Thursday. The airline's plan to end overbooking could be implemented from May 8, according to a Southwest spokeswoman.
comments powered by Disqus
Follow RTT