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news.The FDA has granted Caraco Pharmaceutical Laboratories' tentative approval for the company's abbreviated new drug application for lamotrigine tablets 25mg, 100mg, 150mg, and 200mg. Final approval to market this product is anticipated subsequent to the expiry of patent protection on January 22, 2009.
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This tentative approval is the bioequivalent to Lamictal, a registered trademark of GlaxoSmithKline. Lamotrigine is indicated as adjunctive therapy for partial seizures (the generalized seizures of Lennox-Gastaut syndrome); 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.
Daniel Movens, Caraco’s CEO, 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.”