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FDA adopts interim plan to avoid shortage of medically necessary opioid

Executive Summary

FDA is allowing seven manufacturers and distributors of unapproved high concentration oral morphine sulfate to continue production in an effort to avoid a shortage of the medically necessary opioid. Last month FDA took action against a number of unapproved prescription opioids, asking them to cease their operations. Now the agency is amending this request and will allow 20 mg/mL morphine sulfate oral solution to be produced on an interim basis as a result of concerns from patients and health care professionals in the palliative care community; the agency was swayed by feedback that the discontinuation of the drug would cause a shortage of the opioid that is widely used to alleviate pain in terminally-ill patients. CDER is encouraging drug companies to submit applications for the opioid so it can be approved, noting that it's a "very high-priority product for the agency" and "if a product comes to us, we are going to devote whatever resources we have to make that review efficient, timely and successful.

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