Sepracor Xopenex
Executive Summary
Levalbuterol promotion receives second letter from FDA regarding implied superiority in safety and efficacy for the single isomer product. A May 21 letter from the agency cites journal ads, a sales aid and a "Dear Doctor" letter for the tagline "The Right B-Agonist" as suggesting clinical superiority to racemic albuterol. FDA notes that in clinical trials "Xopenex .63 mg was demonstrated to be clinically comparable to 2.5 mg racemic albuterol sulfate, with only slightly less incidence of certain systemic beta-adrenergic side effects (e.g., tremor, nervousness), and only slightly less change in heartrate and plasma glucose." FDA also objects to statements like "We Wiped Out The (S)-Isomer. Your Patients Don't Need It," and "Xopenex contains only the therapeutically effective right (R)-isomer." FDA previously objected to similar claims made in Sepracor's press release announcing Xopenex' approval ("The Pink Sheet" April 26, p. 15). FDA requests that the company cease distribution of all Xopenex promotional materials that make such claims
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth