ROXANE LABS SUSTAINED RELEASE MORPHINE SULFATE ROXINAL IS NEW DRUG FDA

ROXANE LABS SUSTAINED RELEASE MORPHINE SULFATE ROXINAL IS NEW DRUG FDA told the firm in a recent regulatory letter. Roxanol SR is the second sustained release 30 mg morphine sulfate product to be considered a new drug by the agency. In January, Purdue Frederick was told by the agency that its product, MS Contin was a new drug. In both cases, FDA said it was unaware of either "any controlled-release dosage form of morphine sulfate marketed prior to the" October introduction of the products, or "any scientific studies which establish the safety and efficacy of morphine sulfate in this unique dosage form. In Purdue Frederick's February response to FDA, the firm cited the allowed marketing of Acutrim in support of continued marketing of the morphine product. Purdue Frederick said that Acutrim was a "cogent example" of "other controlled release products [that] have recently been permitted to be marketed without NDA approval" where there is evidence of constant rate of release. Purdue Frederick also argued that "a sustained release product that is not higher in strength than a conventional release preparation which is not a new drug may itself avoid new drug status." Discussions between FDA and Purdue Frederick regarding the new drug status of MS Contin are still ongoing. The firm met with FDA mid-May.