Perrigo Gets FDA Approval for Over-the-Counter Diclofenac Topical Gel

Perrigo announced that the Food and Drug Administration (FDA) has approved the abbreviated New Drug Application for its over-the-counter (OTC) diclofenac sodium topical gel 1% for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults ≥18 years old.

Diclofenac sodium topical gel will be marketed under a retailer store brand label as an alternative to the recently approved Voltaren® Arthritis Pain (GlaxoSmithKline) for nonprescription use. The OTC formulation contains the same amount of diclofenac, a nonsteroidal anti-inflammatory drug, as the prescription strength (10mg of diclofenac sodium per gram).

Perrigo expects to launch the store brand equivalent of Voltaren Arthritis Pain later this year.

For more information visit perrigo.com.