FDA issues warning letters to drug companies for misleading ads
ROCKVILLE, Md. Four drug companies have received warnings from the Food and Drug Administration in the last month for what the agency calls misleading direct-to-consumer advertisements and WebMD Blue Book messages, according to letters the FDA released Tuesday.
The companies include Eli Lilly & Co., for the fibromyalgia drug Cymbalta (duloxetine hydrochloride); Amylin Pharmaceuticals, for the diabetes drug Byetta (exenatide); Cephalon, for the leukemia drug Treanda (bendamustine hydrochloride); and Bayer HealthCare Pharmaceuticals, for the contraceptive Mirena (levonorgestrel).
The FDA alleged that the ads omitted and minimized the drugs’ risks, overstated their efficacy, made false and misleading statements and promoted use of the drugs for unapproved indications.
According to the letter to Cephalon, a dosing card for Treanda omitted details about the safety risks of taking the drug, including that some side effects may be fatal. In the case of Byetta, developed by Amylin and Lilly, a Lilly representative allegedly told an FDA official at the annual meeting of the Endocrine Society that though Byetta was approved only as an add-on therapy for diabetes, it could be used alone and that there were “ways to deal with” issues that might arise with managed care – such as Medicare and Medicaid – when prescribing Byetta alone.
New report projects sales of Parkinson’s disease drug will reach $500 million
WALTHAM, Mass. A drug made by Boehringer Ingelheim for treating Parkinson’s disease could have sales of up to half a billion dollars, according to a new analysis.
According to a report released Tuesday by market research firm Decision Resources, BI’s extended-release formulation of pramipexole will have peak-year sales of between $250 million and $500 million in major pharmaceutical markets. The drug was launched in Europe in 2009 and is expected to enter the market in the United States this year.
In the beginning, according to the report, launches of generic formulations of the immediate-release version of pramipexole and competition from GlaxoSmithKline’s and SkyePharma’s Requip XL (ropinirole CR) and generic versions of immediate-release Requip will put a damper on sales of pramipexole ER. However, physician familiarity with the drug and preference among physicians and patients for once-daily dosing will cause a “significant” increase in sales.
“Given physician comfort in prescribing pramipexole for Parkinson’s disease and the convenience of once-daily dosing that it would offer, we expect that pramipexole ER will take much of pramipexole IR’s patient share,” Decision Resources analyst Sami Fam said. “In the short term, we expect pramipexole ER will lose some patient share to ropinirole CR given that ropinirole CR was the first of the two agents to launch. But over the long term, physicians’ slight preference for pramipexole over ropinirole should help to boost pramipexole ER’s uptake.”
Report: Weis Markets acquires local Medicine Shoppe pharmacy
SUNBURY, Pa. Weis recently acquired a Medicine Shoppe pharmacy in the Binghamton, N.Y., market, local newscaster News Channel 34 (owned by Newport Television) reported early Tuesday morning.
Weis Markets currently has 120 in-store pharmacies at other locations and is considering more at its Broome County locations, the report noted.