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FDA Approved Caraco's Generic Lamictal
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Submitted by Armen Hareyan on 2007, November 14 - 06:17

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.

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.

Source: Caraco Pharmaceutical Laboratories, Ltd.

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