BRUSSELS, Feb. 3 (UPI) -- Belgian firm UCB said Friday its anti-seizure injectable Keppra is "approvable" for U.S. sales.
The company said the Food and Drug Administration has issued an "approvable" letter for Keppra Injection 100 mg/mL, meaning minor issues like labeling are all that remain before UCB can launch the drug on the U.S. market.
The intravenous therapy is approved as adjunctive therapy in the treatment of partial onset epileptic seizures, with or without secondary generalization, in adults and children of four years of age.
Keppra is already sold in the United States in tablet form.
UCB said Keppra also got a positive recommendation from Europe's Committee on Medical Products, meaning the European Commission will now determine whether to clear the treatment for use in the 25 European Union member states.
The drug was previously OK'd in Europe in tablet and oral-solution forms.
"This positive news is an important step in the continuing development of Keppra." said UCB Chief Roch Doliveux. "This new Keppra formulation will be of help to patients and physicians in emergency seizure situations where oral medication is not an option.
"When approved by the regulatory authorities, Keppra will become the first of the newer anti-epileptic drugs to be available in an intravenous formulation," he said.
