FDA Reverses Course, Drugmakers Allowed to Make Morphine Solution

Patient and hospice groups’ concerns have prompted the FDA to reverse its decision that manufacturers of morphine sulfate 20-mg/mL oral solution must stop producing the pain drug. The FDA sent nine warning letters telling companies to halt production of unapproved versions of morphine, hydromorphone and oxycodone products. The FDA is now amending those letters to allow companies to make the 20-mg/mL oral solution to meet the needs of hospice patients with severe pain, CDER Deputy Director Douglas Throckmorton said.