Skip links

Morphine Sulfate Oral Solution-Roxane is First Across the 505(b)(2) Finish Line

Although morphine sulfate oral solution has been used for many years in pain management, it had never been approved by the FDA. As part of their ongoing unapproved drugs initiative, the FDA announced on March 30, 2009 that it was taking enforcement action against Roxane and 6 other firms selling morphine sulfate oral solution. The firms were issued warning letters giving them 90 days to correct the violation (that is, to obtain approval for unapproved product). However, on April 30, 2009, the drug companies received something of a reprieve –  in the form of an FDA announcement that enforcement discretion was being extended until 180 days after any firm received approval for a morphine sulfate solution product. A loud response from the pain management community had convinced the FDA that removing these drugs from the market in July would impose unacceptable hardships on patients and caregivers. The drug companies were still under strict expectations to submit approvable applications for their products, including sufficient efficacy and safety data to meet current FDA standards. In the case of a Schedule II narcotic product like morphine, the applications particularly needed sufficient information on how to safely prescribe and use the drug, including a specific program to address the known risks of morphine misuse, abuse, and overdose.

Yesterday, the FDA announced that Roxane was the first company to receive approval of its morphine sulfate oral solution. The announcement also states that FDA has worked with Roxane to ensure that there will be enough of the approved product for patients, and that prescribers and patient organizations will be made aware that an approved version is available. Cooperation with FDA and efficiency in development of an NDA can lead to first approval for these unapproved marketed drugs. Roxane is in a great position to market its drug while its foot-dragging competitors can only watch.

The approval of the morphine oral solution paves the way for its use as an RLD for other dosage forms containing morphine.