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A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.
Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.
Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.
A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.
Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.
Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.
A concentrated oral solution of morphine sulfate has been approved by the Food and Drug Administration, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for moderate to severe, acute, and chronic pain in opioid-tolerant patients (defined as those who are taking the equivalent of 60 mg of morphine per day). It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is a part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
“It is a significant step toward ensuring that patients needing this medicine have access to a high-quality product,” Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said during the briefing.
Dr. Throckmorton added that actions that “would limit the availability of this medicine could cause unnecessary hardship to these patients and limit the treatment options available to prescribers. As such, we are working with the manufacturer of the approved product, Roxane Laboratories, to make sure that here will be enough approved drug for all patients. We will also be working with patient organizations and prescribers, so that they are both aware of this approved product.
Roxane met the FDA's standard for establishing the safety and efficacy of the oral solution by referring to the agency's prior findings for similar products. The manufacturer also gave the product a standardized drug label and a medication guide.