Healthcare company Perrigo Company plc (NYSE:PRGO) said on Monday that it is the first company to receive approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for over-the-counter (OTC) diclofenac sodium topical gel 1% for the treatment of arthritis pain, with a launch later this year.
Through its prescription (Rx)-to-OTC switch process, the US FDA approved the company's Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription or OTC use .
The company added the product will be marketed under retailer's store brand labels and will provide consumers with a high-quality, value alternative to GSK's Voltaren Arthritis Pain, which is indicated for the temporary relief of arthritis pain.
For the 12 months ending February 2020, the branded and generic prescription sales were USD250, according to IQVIA.
Biocon's first US manufacturing facility inaugurated in Cranbury, New Jersey
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval
Newbury Pharmaceuticals gains Finnish approval for generic melatonin
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)