Duchesnay Contract

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Prior to posting information regarding the reason a drug was removed from the market, it would be wise to educate yourself..........

The combination of doxylamine and vitamin B6 was first introduced to the US market as Bendectin in 1956. At that time, Bendectin was a 3 ingredients prescription medication. The third one, (dicyclomine- a Pregnancy Category B antispasmodic, was omitted from the formulation starting in 1976 due to its lack of efficacy. Bendectin (doxylamine/vitamine B6) was voluntarily removed from the market in 1983 by its manufacturer, Merrell Dow Pharmaceuticals, following numerous lawsuits alleging that it caused birth defects, although an FDA panel concluded that no association between Bendectin and birth defects had been demonstrated.[16] In litigation, Bendectin was supposed to cause all kinds of fetal malformations and problems including limb and other musculoskeletal deformities, facial and brain damage, defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems, blood disorders and cancer.[16] The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals (1993). These suits were led by celebrity plaintiff attorney Melvin Belli .[17] The star witness for the case against Bendectin, William McBride, was later found to have falsified research on teratogenic effects of the drug, and was struck off the medical register in Australia.[18][19]

An extensive review of the evidence submitted in legal proceedings regarding Bendectin has been summarized and found no evidence that the drug in clinical use was linked to birth defects.[20]

The FDA, in 1999, published a statement in the Federal Register that summarized their opinion regarding the safety of pyridxine/doxylamine during pregnancy: “The FDA has determined that the drug product Bendectin, a tablet composed of pyridoxine hydrochloride 10 mg, and doxylamine succinate 10 mg, for the prevention of nausea during pregnancy was not withdrawn from sale for reasons of safety or effectiveness”
 












Territories are beyond huge. This drug will have 0 coverage. Saying that it will be a "touch sell" will be the understatement of the year! $500 a month car allowance, and $.19 per mile, won't make up for all the costs associated with geographies this big.
 


















This is going to be a dog product and contract. Doctors use ondansetron for morning sickness, there are too many good ones out there such as Zuplenz which is an oral dissolving strip that tastes like peppermint, or Zofran oral dissolving tablet. Safer, easy, and actual managed care coverage.
 






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