Generics
Perrigo wins US FDA final approval for AB rated generic Voltaren Gel 1%
22 May 2019 -

Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Tuesday the receipt of the final approval from the US Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) generic Voltaren Gel, 1% (diclofenac sodium topical gel, 1%).

Voltaren Gel, a nonsteroidal anti-inflammatory drug (NSAID) in topical form, is mostly used on knees and hands, according to the company.

The US FDA approval was awarded to the company's partner, upon which, the company will acquire full ownership of the ANDA under a pre-existing arrangement with its partner within 30 days. The product is expected to be launched within the next two months.

For the 12 months ending March 2019, the annual market sales for the Voltaren Gel, 1% were approximately USD350m as measured by IQVIA.

In conjunction with the approval, the company will manufacture diclofenac sodium topical gel 1% in its plant in Israel. The product was developed through its partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.

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