Perrigo gets tentative FDA approval for generic Ultravate lotion
Perrigo has received tentative approval from the Food and Drug Administration for the first to file generic version of Ultravate lotion (halobetasol propionate) 0.05%.
Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries and MiCal Pharmaceutical for this product.
Ultravate lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients age 18 years old and older.
The product had a market value of about $17 million for the 12 months ending September 2018, according to IQVIA.
"Our R&D team continues its efforts to secure regulatory approvals for important new products. This tentative approval reflects our continued dedication to developing extended topical products for patients and further illustrates our commitment to advancing our new product pipeline," Perrigo executive vice president and president of Rx pharmaceuticals Sharon Kochan said.
Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries and MiCal Pharmaceutical for this product.
Ultravate lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients age 18 years old and older.
The product had a market value of about $17 million for the 12 months ending September 2018, according to IQVIA.
"Our R&D team continues its efforts to secure regulatory approvals for important new products. This tentative approval reflects our continued dedication to developing extended topical products for patients and further illustrates our commitment to advancing our new product pipeline," Perrigo executive vice president and president of Rx pharmaceuticals Sharon Kochan said.