Reports: Takeda sues Amneal over generic version of Colcrys
NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.
Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.
Amneal earlier this year applied for approval of generic colchicine in gout patients, asserting that Takeda’s patents covering the gout indication were invalid and triggering a lawsuit from Takeda, but later withdrew the application. The latest lawsuit relates to an effort by Amneal to win approval for the drug as a treatment for familial Mediterranean fever, or FMF, a rare genetic disease.
FDA approves Lundbeck’s Sabril in children
DEERFIELD, Ill. — The Food and Drug Administration has approved a drug made by Lundbeck for treating a form of epilepsy in children, the drug maker said.
Lundbeck announced the approval of Sabril (vigabatrin) as an add-on therapy for refractory complex partial seizures in children ages 10 years and older who have not responded adequately to other treatments, as long as the benefit of treatment outweighs the risk of vision loss. The drug was already approved for treating the same condition in adults in 2009.
CPS affects about 35% of the more than 2 million Americans with epilepsy. CPS originates from from a single region of the brain and can cause impaired consciousness, and about 30% to 36% of those with it continue to have seizures despite trying multiple drug therapies, according to medical research.
Actavis sales jump 57% in Q3
DUBLIN — Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.
Profits for the quarter were $65.5 million, down from $76.7 million in third quarter 2012. The quarter’s results exclude figures from Ireland-based Warner Chilcott, which Actavis acquired at the beginning of the month.
For the company’s generics business, highlights of the quarter include the launch of generic versions of Endo Pharmaceuticals’ painkiller Opana ER (oxymorphone); Endo’s painkiller patch Lidoderm (lidocaine); and the Food and Drug Administration’s approval of a generic version of GlaxoSmithKline’s epilepsy and bipolar disorder treatment Lamictal ODT (lamotrigine).
"Double-digit revenue and earnings growth marked another exceptional quarter for Actavis Inc. as we continue to accelerate our transformation into a global specialty pharmaceutical leader," Actavis chairman and CEO Paul Bisaro said. "Strong global growth in our Actavis Pharma segment was driven by our ability to capitalize on product opportunities from our industry-leading R&D pipeline."
The company’s Actavis Specialty Brands segment, which makes drugs for indications like contraception and bladder problems, also experienced strong sales, Bisaro said.