Avanir sues Par, Actavis over generic versions of neurological drug
ALISO VIEJO, Calif. — Drug maker Avanir Pharmaceuticals has filed suit against two generic drug makers seeking to launch versions of a drug used to treat pseudobulbar affect, which causes sudden, involuntary episodes of laughing and crying, and occurs secondary to numerous other neurological conditions.
Avanir filed the suit in the U.S. District Court for the District of Delaware against Par and Actavis, which had filed for regulatory approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate).
Avanir alleged that the the generics made by Par and Actavis would violate U.S. Patent Nos. 7,659,282 and RE38,115, set to expire in August 2026 and January 2016, respectively.
Pharmacists, dentists raise awareness of medication-related dry mouth
CHICAGO — A lot of prescription and OTC medications carry the side effect of dry mouth, and while it usually is a mere nuisance that quickly passes, its severe forms can increase the risk of mouth sores, infections and tooth decay, especially among elderly patients.
Because of this, dentists and pharmacists are looking to raise awareness of medication-induced dry mouth, known by health professionals as xerostomia, in a campaign that brings together the American Pharmacists Association, the American Dental Association, the Academy of General Dentistry and the American Academy of Periodontology.
"Each day, a healthy adult normally produces around one-and-a-half liters of saliva, making it easier to talk, swallow, taste, digest food and perform other important functions that often go unnoticed," Academy of General Dentistry president Fares Elias said. "Those not producing adequate saliva may experience some common symptoms of dry mouth."
GSK, XenoPort file sNDA for Horizant
LONDON — Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.
The drug makers this week announced the submission of a supplemental new drug application to the Food and Drug Administration, requesting approval for Horizant (gabapentin enacarbil) extended-release tablets as a treatment for postherpetic neuralgia, a nerve pain that commonly is seen in patients with shingles. GSK submitted the sNDA on behalf of the two companies.
Horizant initially received regulatory approval from the FDA in April as a treatment for moderate to severe primary RLS.