Advertisement New Looks For FDA Approved Roxane's Morphine Sulfate 100mg per 5ml Oral Solution - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

New Looks For FDA Approved Roxane’s Morphine Sulfate 100mg per 5ml Oral Solution

In January 2010, FDA has approved Morphine Sulfate oral solution 100mg per 5ml (20mg/ml) for relief of moderate to severe acute and chronic pain in opioid-tolerant patients. The approval of the product is part of FDA’s unapproved drugs initiative.

The company said that as part of this effort, FDA is committed to being proactive to assist companies with finding opportunities to legally market products that are currently marketed without the required FDA approval.

The FDA approval process ensures that marketed drugs meet current FDA standards for safety, efficacy, quality, and labeling. For many years, Roxane Laboratories (Roxane) had marketed an unapproved version of the morphine sulfate oral solution 20mg/ml to manage pain; the newly approved product, also from Roxane, is the only morphine sulfate oral solution currently approved by the FDA at a concentration of 100mg per 5ml (20mg/ml).

Additionally, because this product underwent the required FDA approval process, FDA and Roxane were able to work together to improve the packaging and labeling in order to help avoid medication errors and promote the safe use of the product.

Prior to the recent approval, Roxane has marketed an unapproved morphine sulfate oral solution with the strength expressed as 20mg/ml, using a container label and carton labeling that had brown lettering on a white background.

The design of the old label was very similar to other FDA-approved Roxane products, including other strengths of morphine sulfate oral solutions (10mg/5ml, and 20mg/5ml). Thus, the visual similarity of these products and similar expression of product concentrations often led to confusion between the different strengths of morphine products.

The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors. Additionally, the new prescribing information highlights the risk of medication errors with this product.