Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade IPXL now with 

Impax Laboratories, Inc. (IPXL: Quote), 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.

Click here to receive FREE breaking news email alerts for Impax Laboratories Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Russia has agreed to resume gas supplies to Ukraine under a $4.6 billion dollar winter package, which will also secure gas for the European Union as the cold season approaches. The European Union has been mediating discussions to help find a sustainable solution to the dispute between Russia and Ukraine over gas pricing, supply and payment dues. After seven rounds of negotiations in recent months The Bank of Japan expanded its massive quantitative and qualitative easing unexpectedly as policymakers assessed it necessary to achieve the 2 percent inflation target even after a sales tax hike in April. In a 5-4 vote, the Policy Board led by Governor Haruhiko Kuroda decided to raise the monetary base at an annual pace of about JPY 80 trillion. LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.