Reports: Merz Pharmaceuticals sues Par over cerebral palsy drug
NEW YORK — Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter’s attempt to market a generic drug for cerebral palsy patients, according to published reports.
Bloomberg reported that Merz sued Par in the U.S. District Court for the District of Delaware after Par attempted to apply for Food and Drug Administration approval for a generic version of Cuvposa (glycopyrrolate) oral solution, used to treat severe drooling in cerebral palsy patients.
The drug received FDA approval this year, and Merz bought rights to the drug in August.
Generic drug safety labels often contain incorrect information, study finds
INDIANAPOLIS — More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.
Researchers at the Regenstrief Institute, a research organization supported by the Regenstrief Foundation and located on the campus of Indiana University Purdue University Indianapolis, reviewed 9,105 product labels for more than 1,500 drugs available on the Food and Drug Administration’s and National Library of Medicine’s online labeling information repository DailyMed. Of more than 1,040 drugs with more than one manufacturer’s label, 68% had discrepancies within their safety information.
Using a software program they developed, the researchers found that most of the generic showed relatively small differences, but 9% showed differences of more than 10 side effects, and other errors included out-of-date information, incomplete data and one that had information for the wrong drug. The study was published online in the journal Pharmacoepidemiology and Drug Safety and will be published in the print edition as well.
"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions," lead study investigator and Indiana University professor of medicine Jon Duke said. "They need to know about side effects, drug interactions and other safety issues. We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug."
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Most prescribers would pick biosimilar RA drugs
BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.
Market research firm Decision Resources found that about 80% of current prescribers of Johnson & Johnson’s and Merck’s Remicade (infliximab) and Rituxan (rituximab), made by Biogen Idec and Roche, would prescribe biosimilar versions, but about half of them said they would prescribe biosimilar versions only if a patient requests it or insurance plans demand it, and most do not plan to prescribe the branded versions to patients who fail treatment with the biosimilars.
At the same time, half of commercial plans that cover the branded drugs will not likely cover biosimilar versions of either drug by 2015, while only one-third of Medicare Part D plans that cover Remicade and Rituxan would exclude biosimilars.
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