VIVUS, Inc.(NASDAQ:VVUS) has called for a reconsideration of, and an amendment of the Risk Evaluation and Mitigation Strategy requirement. The FDA had asked the company to get REMS for their new anti-obesity drug, which the pharmaceutical now wants to be looked into, again. Qsymia, which is the drug, is not widely available at present due to the Risk Evaluation and Mitigation Strategy. But if the FDA does look into it, and agree to the reconsideration, then the drug can be made more widely available to many more consumers.
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The FDA had approved the drug, but they had put the REMS clause in place. This was done in July, this year. Under the strategy, the prescription for the anti-obesity drug would have to be mail order pharmacies which were qualified enough. Training from healthcare provider, Medication guide, educational tools ad well as patient brochure were the other specifications which the FDA placed. Vivus had made a deal with the pharmacy chain of Express Scripts with regards to the prescriptions clause. REMS requirements may not be very stringent, but they do restrict the widespread availability of the drug. Vivus, keeping in mind the greater distribution of the medicine, has called for the reevaluation. After it got approved by the FDA with the clause in July, the medicine was launched to the public in September, around the middle of the month.
The company may have been selling Qsymia only for about a month now, but they have already managed to get themselves a distribution deal, and they want their medicine to be more widely available, to increase sales and popularity, hence the bold demand from the FDA. Vivus, however, has not been there on the news for all the good reasons. The company’s negligence to get approval from Europe has been talked about, a fair amount. The market is also waiting to get proof of the results of Qsymia. If the drug manages to sell well enough, then Vivus equity might grow quite a lot. About ten percent of growth is the average anticipated rate.