FDA approves Roxicodone generic
MUMBAI, India Sun Pharmaceutical Industries said on Monday it had received approval from the Food and Drug Administration to sell a generic version of a painkiller medication.
Sun’s generic is marketed after Roxicodone (oxycodone hydrochloride) tablets. Roxicodone is manufactured by Xanodyne Pharmaceuticals.
Xanodyne Pharmaceuticals has developed and produced Roxicodone since 2005, after the company completed an acquisition of aaiPharma’s pharmaceuticals division.
Merck, Cardiome Pharma to collaborate, develop atrial fibrillation treatment
VANCOUVER, B.C. Merck & Co. and Cardiome Pharma Corp. announced this week that they would collaborate to develop and commercialize a drug being investigated as a treatment for atrial fibrillation.
The agreement provides Merck with exclusive global rights to the oral formulation of vernakalant, designed for the maintenance of normal heart rhythm in patients with atrial fibrillation. It also provides Merck with exclusive rights outside North America for an intravenous formulation of the drug used for rapid treatment of the disease.
“This agreement underscores Merck’s ongoing commitment to the research and development of new cardiovascular drugs,” Merck Research Laboratories SVP and franchise head of atherosclerosis and cardiovascular Luciano Rossetti said. “Vernakalant is an important addition to our broad portfolio of products and candidates that target multiple aspects of heart disease.”
FDA approves new topical treatment of head lice
ROCKVILLE, Md. The Food and Drug Administration has approved a new prescription topical medication for treating head lice, the agency announced Thursday.
Sciele Pharma’s Benzyl Alcohol Lotion, 5% is the first head lice treatment approved by the FDA that uses benzyl alcohol as its active pharmaceutical ingredient. It is meant for patients ages 6 months and older.
“Head lice are a problem that impacts more than 1 million children each year and is easily transmitted to others,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This drug is an effective first-line treatment to eliminate lice infestation and minimize disruption in the daily routines of families.”