UCB launches liquid Vimpat
ATLANTA An oral liquid version of an epilepsy drug made by UCB has become available, UCB said Monday.
The drug maker announced the availability of the oral solution formulation of Vimpat (lacosamide) C-V in the 10-mg-per-milliliter strength. The drug is also available as an intravenous injection and in tablet form. Vimpat is used as an add-on treatment for partial-onset seizures.
“Having Vimpat available as an oral solution is very good news,” director of the University of Minnesota’s Epilepsy Research and Education Program Ilo Leppik said in a statement on behalf of UCB. “There are many people for whom swallowing pills is difficult, and the oral solutuion, which can be substituted milligram-for-milligram to the oral tablet, will be helpful to adults with swallowing difficulties.”
Gilead patent for Ranexa challenged by Lupin
FOSTER CITY, Calif. Indian generic drug maker Lupin is challenging a Gilead Sciences patent for a drug that treats chronic angina, Gilead said.
Gilead said it received a notice that Lupin had filed an approval application with the Food and Drug Administration for a generic version of Ranexa (ranolazine) extended-release tablets. Lupin’s application contained a Paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that Gilead’s patents covering Ranexa are invalid, unenforceable or won’t be infringed by Lupin’s version.
Under the Hatch-Waxman Act, Gilead has 45 days from the receipt of the letter to file a patent infringement lawsuit against Lupin. Such a suit would prohibit the FDA from approving Lupin’s version of the drug for two and a half years or until the court rules against Gilead. The patents covering Ranexa are set to expire in 2019, according to FDA records.
Taro sales rise in Q1
HAWTHORNE, N.Y. First-quarter sales for Taro Pharmaceutical Industries increased by 5.2% to $89.3 million from $84.9 million in first quarter 2009, the Israeli generic drug maker said Monday.
Profit for the quarter was $10.2 million, compared with $11.1 million in first quarter 2009, including a $3.8 million decrease resulting from foreign exchange expenses related to changes in rates between the U.S. and Canadian dollars.