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FDA gives green flag to new Over-the-Counter Diclofenac topical gel

FDA gives green flag to new Over-the-Counter Diclofenac topical gel FDA gives green flag to new Over-the-Counter Diclofenac topical gel
FDA gives green flag to new Over-the-Counter Diclofenac topical gel FDA gives green flag to new Over-the-Counter Diclofenac topical gel

What's new?

Doctors could recommend over-the-counter (OTC) diclofenac sodium topical gel 1% for temporary relief of arthritis pain as it got FDA approval for the same.

A well-known manufacturer of private label over-the-counter pharmaceuticals declared that the FDA has accepted the abbreviated New Drug Application for its OTC diclofenac sodium topical gel 1%. This medication is used for the short-term pain relief in foot, ankle, knee, elbow, wrist or hand of arthritis patients aged 18 years and above.

Diclofenac sodium (a nonsteroidal anti-inflammatory drug, NSAID) topical gel will be marketed under a retailer store brand label as a substitute to the newly accepted Arthritis Pain relief formulation (diclofenac sodium topical gel, 1%) by another multinational company for non-prescription use.

The OTC formulation has the equivalent amount of diclofenac as the recommended strength (diclofenac 10 mg per gram). This drug is expected to launch later this year.

Source:

Perrigo

Article:

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

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