DETROIT, April 2 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. has launched Topiramate tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma), immediately following Sun Pharma’s recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Topamax(R) tablets.
Topiramate tablets are used as initial monotherapy in patients 10 years of age and older with partial onset seizures, or primary generalized tonic-clonic seizures. Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. These generic versions of Topamax 25 mg, 50 mg, 100 mg, and 200 mg tablets are bioequivalent to Topamax(R) which is a registered trademark of Ortho McNeil Janssen Pharmaceuticals, Inc. According to IMS Data, these strengths of Topiramate had US sales of approximately $2.3 billion for the calendar year of 2008.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are pleased to add this product to our portfolio by launching Topiramate tablets immediately to the marketplace. We continue to focus on working towards expanding our product offering both as a marketing partner and through our own development pipeline of products as quickly and effectively as possible.”
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation’s filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
CONTACT: Daniel Movens, +1-313-871-8400, or Thomas Versosky,
+1-313-556-4150, both of Caraco Pharmaceutical
