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FDA Decision Encourages Lamictal Generics

As the FDA cannot approve an abbreviated new drug application (ANDA) for a listed drug that has been withdrawn due to reasons of safety or efficacy// , the agency had to determine the reasons for the withdrawal before approving any generic version.

The investigation found no evidence of safety or efficacy issues, and the FDA has announced that it can approve ANDAs provided all other legal and regulatory requirements are met. The FDA added that the ruling was in response to a citizen's petition from a patent attorney that was filed in June 1995.

However, even if rival drug makers were to file an application for the drug, the respective company could still face a patent suit from Glaxo as the patent in the US is not due to run out until 2009. Lamictal already faces generic competition in Europe, where its patents have expired.

Lamictal (lamotrigine) is an antiepileptic drug indicated as adjunctive therapy for partial seizures in adults and pediatric patients. It is also approved for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug or valproate. In addition, Lamictal is indicated for the maintenance treatment of bipolar I disorder in certain patients.

Source-Bio-Bio Technology
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