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

Editors Pick
Automakers on Monday reported strong U.S. vehicle sales for the month of July, driven by continued demand for trucks and sport-utility vehicles amid an improving economy, lower gas prices and easy availability of credit. Detroit's Big Three - General Motors Co., Ford Motor Co. and FCA US, LLC - all reported vehicle sales above analyst expectations. British lender Lloyds Banking Group Plc. Friday reported higher profit in its first half, benefited by increased net interest income and margin as well as lower impairment. Looking ahead, the company lifted its net interest margin forecast. Amgen reported an increase in second-quarter profit, driven by sales of arthritis drug Enbrel and osteoporosis treatments Xgeva and Prolia, and improved margins. Both earnings and sales topped Wall Street estimates.
comments powered by Disqus
RELATED NEWS
Trade IPXL now with 
Follow RTT