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
European Court of Justice in Luxembourg has canceled the international agreement between European Union and United States to handover digital information, such as web search histories and social media updates. The ruling will be a blow to tech giants Google, Microsoft, Facebook, Amazon, etc. Volkswagen Australia Wednesday confirmed that more than 91 thousand vehicles sold in Australia were fitted with emission cheating software. Volkswagen brand alone comes to 77,000 cars and 14,000 cars are Audis. In what could be a delectable offering, something is cooking in the brewing industry. Belgian brewer Anheuser-Busch Inbev, which in itself is an outcome of many mergers in the past, has made advances to U.K.'s SABMiller. If AB InBev succeeds in its pursuit, the heady combination of the two could create one of the world's largest brewers.
comments powered by Disqus
Trade IPXL now with 
Follow RTT