FDA Approves Ampyra Bioequivalent for Multiple Sclerosis

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The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg).

The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg). The agency’s Division of Bioequivalence determined the product is the bioequivalent of Ampyra from Acorda Therapeutics, and it is indicated for the treatment of multiple sclerosis (MS).

Ampyra’s main ingredient is dalfampridine, which works to block potassium channels in the body. In turn, MS patients may see an improvement in walking and an increase in walking speed.

The most common adverse effects associated with Ampyra are urinary tract infection, insomnia, dizziness, headache, nausea, weakness, and back pain.

The drug may cause seizures in some patients. In studies, those who used 20 mg of Ampyra twice daily showed an increased incidence of seizures. The drug has not been studied in patients with a history of seizures.

Aurobindo’s product portfolio now consists of 256 final approvals, including 39 tentative approvals and 16 approved products from Aurolife.

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