FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml
FDA remains committed to taking enforcement actions against unapproved drugs in an effort to ensure that drugs used by patients are safe and effective, while at the same time ensuring that such actions do not impose an undue burden on patients. Currently, there are no approved morphine sulfate oral solution 20 mg/ml products being marketed in the U.S. FDA has heard from the pain management community that the impending market removal of unapproved morphine sulfate oral solution 20 mg/ml products announced in the Warning Letters would impose unacceptable hardship on palliative care patients, their families and caregivers. In light of this information, FDA will extend the enforcement discretion set forth in the Warning Letters to ensure that palliative care patients have access to morphine sulfate oral solution 20 mg/ml. The period of enforcement discretion will be extended until 180 days after any firm receives approval for a morphine sulfate oral solution 20 mg/ml product or if FDA determines that alternative medications become available for the palliative care patient.
FDA reiterates its expectation that all firms that market unapproved drugs to the American public submit the required applications to obtain approval for those products.
Letters to companies
- Glenmark Generics Inc.
- Lannett Company, Inc.
- Lehigh Valley Techologies Inc.
- Mallinckrodt Inc. Pharmaceuticals Group
- Xanodyne Pharmaceuticals Inc.
- Boehringer Ingelheim Roxane Inc.
- Cody Laboratories, Inc.