Ivax Corporation has filed status on gabapentin tablets in 100 mg, 300 mg and 400 mg dosage strengths. Gabapentin is the active ingredient in Neurontin which is marketed by Warner-Lambert, a unit of Pfizer Inc.
Neurontin is marketed by Warner-Lambert in 5 dosage strengths, 100 mg, 300 mg and 400 mg capsules, and 600 mg and 800 mg tablets. Ivax has amended a previously filed ANDA to include tablets in 100 mg, 300 mg and 400 mg dosage strengths and believes that it has first to file status on gabapentin tablets in these strengths. Tablets in these strengths are not currently marketed and, upon approval, Ivax plans to market them to HMOs and other institutional purchasers as Gabaron, a lower priced brand alternative.
Ivax also has ANDAs pending for the 100 mg, 300 mg and 400 mg capsules, and 600 mg and 800 mg tablets currently marketed by Warner-Lambert, and was previously notified by the FDA that its ANDA for the 100 mg, 300 mg and 400 mg capsules is approvable. Upon receiving final approval Ivax will market these dosages as generic equivalents through its subsidiary Ivax Pharmaceuticals Inc.
Ivax currently has 34 ANDAs and two tentative approvals pending at the FDA. The company is continuing its aggressive filing schedule for new ANDA submissions.