Roxane Laboratories gets 1st FDA approval for widely-used morphine formulation

FDA approves widely-used morphine formulation

WASHINGTON — The Food and Drug Administration says it has confirmed the safety of a widely-used formulation of morphine that was previously unapproved.

The agency approved Roxane Laboratories’ Morphine Sulfate oral solution for patients with moderate to severe chronic pain.

Doctors have used the formulation for years, but it was previously not approved by FDA regulators.

In March, the FDA issued warning letters to Roxane and eight other drugmakers, ordering them to stop distributing their morphine drugs. While the FDA tries to review all new drugs before they are launched, some older medications have never received formal review.

The Roxane approval is part of FDA’s effort to make sure all drugs on the market meet safety and effectiveness standards.