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FDA Approves Generic Morphine Formulation to Answer Shortage After Pulling Unapproved Opiod Pain Products

Posted Apr 14 2010 10:45pm

If you remember last month the FDA pulled a number of products from the market so here’s an oral solution that is now approved. 

The morphine elixir is widely used by terminal patients in hospital and home hospice care settings and is manufactured by Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group, Boehringer Ingelheim Roxane Inc. and Cody Laboratories, Inc.  BD image

The FDA has approved a generic formulation of 100 mg/5 mL (20 mg/mL) morphine sulfate oral solution from Roxane Laboratories, which will now allow the agency to follow through on an initiative to pull unapproved opioid pain products from the market.

On March 31, 2009, as part of its ongoing Unapproved Drugs Initiative, the FDA sent warning letters to the makers of 14 unapproved opioid products, citing possible enforcement action if manufacturing and distribution of unapproved prescription pain products was not halted within 60 and 90 days, respectively.

Concern centered on the potential for making pain control for patients receiving end-of-life care more difficult by removing the easy-to-swallow 20 mg/mL morphine liquid from the market.

“This is the only FDA-approved morphine sulfate oral solution available at this concentration,” the FDA said on its Web site in announcing the new approval. “The firm [Roxane Laboratories] has sufficient supply to meet the entire market demand and no shortage is anticipated.”

Morphine 20 mg/5 mL and 10 mg/5 mL remain available as approved products.

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