Perrigo awarded US FDA tentative approval for first to file generic Ultravate Lotion 0.05%
27 November 2018 -

Healthcare company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) reported on Tuesday the receipt of tentative approval from the US Food and Drug Administration for the first to file generic version of Ultravate Lotion (halobetasol propionate) 0.05%.

The company added that the Ultravate Lotion, 0.05% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

In conjunction, the company has announced a patent litigation suit with Sun Pharmaceutical Industries Inc and MiCal Pharmaceuticals LLC for Ultravate Lotion, 0.05%.

For the 12 months ending September 2018, the annual market sales were approximately USD17m as measured by IQVIA, concluded the company.