Roxane Laboratories announced that the New Drug Application (NDA) for high concentrate morphine sulfate oral solution 100mg/5mL (20mg/mL) has been approved by the FDA. In March 2009, the FDA halted the marketing of certain unapproved prescription narcotic drugs, including morphine sulfate oral solution. Roxane currently has a sufficient supply of FDA-approved morphine sulfate oral solution 100mg/5mL to meet market demand and is not anticipating a shortage. Roxane will be transitioning to new packaging, labeling, and NDC numbers in the near future. Until then, high concentrate morphine sulfate oral solution is available from Roxane under the following NDC numbers:
- NDC 0054-0352-44 Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL Bottle
- NDC 0054-0352-50 Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 120mL Bottle
Morphine sulfate oral solution is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
For more information call (800) 962-8364 or visit www.roxane.com.