Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal
DETROIT, Nov. 12 -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets (lamotrigine), 25 mg, 100 mg, 150 mg, and 200 mg. Final approval to market this product is anticipated subsequent to the expiry of patent protection on January 22, 2009.
Lamotrigine is indicated as adjunctive therapy for partial seizures (the generalized seizures of Lennox-Gastaut syndrome), is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED, and is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.
This tentative approval is the bioequivalent to Lamictal(R), a registered trademark of GlaxoSmithKline. Lamictal(R) tablets had U.S. sales of approximately $1.89 billion for the 12-month period ended September 30, 2007, according to IMS Data.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent in January 2009, which will allow Caraco to market the product. We feel that generic Lamictal(R) will be a positive addition to our portfolio by expanding our product offerings."
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.