FDA Approved Caraco's Generic Lamictal

Armen Hareyan's picture
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FDA has granted tentative approval for Caraco Pharmaceutical Laboratories'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.

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This tentative approval is the bioequivalent to Lamictal, a registered trademark of GlaxoSmithKline. Lamictal 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 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.

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