FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Jan 27 2010

Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration. This product is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.

Roxane Laboratories', Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) is the only FDA approved Morphine Sulfate Oral Solution CII available at this concentration. Roxane Laboratories, Inc. has sufficient supply to meet the entire market demand and no shortage is anticipated. Roxane Laboratories, Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL), will be transitioning to new packaging, labeling, and NDC numbers in the near future. In the mean time, please continue to use the following Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 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

Roxane Laboratories, Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL is available for immediate shipment to wholesalers and pharmacies nationwide.