Novartis Receives Approvable Letter for Trileptal from FDA

Novartis Pharmaceuticals Corporation announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for Trileptal(R) (oxcarbazepine) tablets, a new therapy for the treatment of partial seizures in adults and children. The approvable letter represents the final step before a product receives FDA clearance for marketing in the United States. Trileptal has been shown to be effective in clinical trials involving over 3,000 subjects, with higher doses associated with greater efficacy.

Key Takeaways:

• Trileptal, an anticonvulsant or antiepileptic drug (AED), received an approvable letter from the FDA for the treatment of partial seizures in adults and children.
• The approvable letter is the final step before a product receives FDA clearance for marketing in the United States.
• Trileptal was evaluated for marketing clearance based on results from 29 trials involving more than 3,000 subjects, showing patients treated with Trileptal were clinically improved compared to those on placebo or low doses.
• Trileptal has been marketed in 51 countries since 1990, with common side effects including headache, somnolence, dizziness, viral infection, and nausea.
• A less commonly seen side effect is hyponatremia (low serum sodium levels), which is usually asymptomatic and does not usually require therapy adjustments.
• Novartis Pharmaceuticals Corporation researches, develops, manufactures, and markets leading innovative prescription drugs used to treat a number of diseases and conditions.

Statistics:

• 29 trials were conducted to evaluate Trileptal for marketing clearance.
• Over 3,000 subjects were involved in the clinical trials.
• Trileptal has been marketed in 51 countries since 1990.
• Common side effects of Trileptal include headache, somnolence, dizziness, viral infection, and nausea.
• Total sales for the Novartis group of companies in 1998 were $21.8 billion.

Sources:

• PRNewswire, "Novartis Pharmaceuticals Corporation Receives Approvable Letter for Trileptal from FDA"
• Novartis Pharmaceuticals Corporation, "Trileptal(R) (Oxcarbazepine) Tablets"