UCB seeks approval for Vimpat as stand-alone therapy in adults
ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.
The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.
"UCB has a strong heritage in epilepsy," UCB chief medical officer and EVP Iris Loew-Friedrich said. "The US filing for lacosamide in monotherapy is another step forward for people living with epilepsy."
Mylan files for approval of generic gout drug
PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.
Mylan has filed with the Food and Drug Administration for approval of a generic version of Uloric (febuxostat) tablets in the 40-mg and 80-mg strengths, used for chronic treatment of hyperuricemia in patients with gout. Teijin owns the trademark for the drug and licenses it to Takeda, and both companies responded to the filing with a patent-infringement suit against Mylan in the U.S. District Court for the District of Delaware. The lawsuit was filed under the Hatch-Waxman Act of 1984 and places a stay of FDA approval on the generic drug for 30 months, or until the companies settle.
Uloric had sales of about $260.7 million during the 12-month period that ended in June, according to IMS Health. As the first company to win approval for a generic version of the drug, Mylan would have 180 days in which to compete exclusively against Teijin and Takeda.
FDA approves two Novo Nordisk insulin pens
PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.
Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).
FlexTouch is a new profiled insulin delivery system that allows patients to administer insulin by pressing a low-dose-force button. In traditional insulin pens, a push button extends when a dose is dialed, which can present challenges for a patient at higher doses, the company said.