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.
Ranbaxy global sales rise in Q3
GURGAON, India — Ranbaxy Labs had global sales of $447.6 million in third quarter 2013, compared with $434.6 million in third quarter 2012, the Indian drug maker said Tuesday.
Sales from generics were $208.4 million, while branded and OTC drugs had sales of $239.3 million North American sales were $143.24 million including $128.6 million in the United States, lower than in Q3 2012 due to a large contribution last year from new generic drugs.
"The company continues to grow in its focus branded markets in Asia, East Europe, CIS and Africa," Ranbaxy CEO and managing director Arun Sawhney said. CIS refers to the Commonwealth of Independent States, comprising countries in the former Soviet Union. "In India, however, the announcement of the pricing policy caused some uncertainty in the market, during which our sales in the home market faced some disruptions."