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Executive Summary

PURDUE FREDRICK WILL SUBMIT NDA FOR MS CONTIN at the request of FDA. The company agreed to file an NDA for the 30 mg morphine sulfate continuous release product at a June 14 meeting with Com. Young and other FDA officials. According to an FDA memo of the meeting, Purdue Frederick will also submit a compassionate IND "so that distribution of [MS Contin can] be continued to patients who would benefit from the availability of this product while the NDA is being reviewed." FDA's memo noted that Com. Young "expressed [the agency's] concern for patients for whom the drug appears to be beneficial and indicated FDA's willingness to work with the company to establish a mechanism whereby treatment with MS Contin could be continued under an IND." MS Contin has been on the market since October 1984. In January, FDA told the firm that MS Contin was a new drug since it was a new dosage of morphine and there were no studies establishing the safety and efficacy of the controlled release form. Purdue Frederick argued that the sustained release product "is not higher in strength than a conventional release preparation." The company had cited FDA's allowed marketing of sustained release Acutrim as a precedent for continued marketing of MS Contin. Purdue Frederick said it agreed to submit an IND and NDA "to resolve the dispute and not because it agreed with FDA that MS Contin is a new drug," FDA's memo noted. The agency has been discussing the new drug status of a controlled release morphine formulation with Roxane. The agency sent that firm a regulatory letter in May declaring that the company's Roxanol 30 mg sustained release morphine sulfate product is a new drug, requiring NDA approval.

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