Cochrane reports OTC cough-cold medicines show efficacy in adults
WASHINGTON Cochrane Collaboration, an independent, international not-for-profit that produces systematic reviews of healthcare interventions, on Tuesday released a review of existing data on the efficacy of oral over-the-counter cough medicines in children and adults.
“Consumers should continue to remain confident that their OTC cough remedies provide the same symptomatic relief as in past cold seasons,” stated Heinz Schneider, vice president, regulatory and scientific affairs for the Consumer Healthcare Products Association. “As the authors of this review indicate, common cold research is challenging—especially in younger populations. CHPA has presented positive efficacy data in adults to the U.S. Food and Drug Administration and has already begun to work with experts and FDA on methodologies for further research on the effects of medicines on common cold symptoms in children.”
While this review includes a limited number of OTC medicines available in the U.S., the majority of studies show statistically significant improvement in adult populations, the Cochrane Collaboration reported.
Ranbaxy, GSK settle over Imitrex litigation
HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.
The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.
Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.
FDA delays Kynapid decision pending final review
VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.
The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.
“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.