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June 1, 2021Zipsor Indication Expanded to Include Adolescent Patients
May 28, 2021 – The U.S. FDA has approved an expanded indication for Zipsor® (diclofenac potassium), manufactured by Assertio Therapeutics, to provide relief of mild to moderate acute pain in patients who are at least 12 years old. Zipsor first received FDA approval in 2009 for use in adults.
While diclofenac potassium, the active pharmaceutical ingredient (API) of Zipsor, is available as an API in other drugs, Zipsor comes in a proprietary, immediate release, liquid-filled gelatin capsule 25mg dosage form. It is not interchangeable with other dosage strengths or formulations of oral diclofenac potassium.
Recommended dosing is one capsule taken by mouth four times daily. A black box warning cautions that nonsteroidal anti-inflammatory drugs (NSAIDs) such as Zipsor can increase the risk of serious, potentially fatal cardiovascular and gastrointestinal (GI) events such as heart attack, stroke, GI ulcers and bleeding, and perforation of the stomach or intestines.