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FDA approves first generic version of Dovonex cream
FDA has approved Sandoz's calcipotriene cream, the first generic version of Dovonex Cream, 0.005% (Leo Pharma), for the treatment of plaque psoriasis.
FDA has approved Sandoz’s calcipotriene cream, the first generic version of Dovonex Cream, 0.005% (Leo Pharma), for the treatment of plaque psoriasis.
Psoriasis is the most common autoimmune disease in the United States, and as many as 7.5 million Americans have the disease, according to the National Psoriasis Foundation.
"Sandoz is proud to be both the first company to file for and the first to launch this important new generic dermatology medicine, which further strengthens Sandoz’s No. 1 position in generic dermatology medicines in the US and globally,” said Don DeGolyer, president of Sandoz US, in a press release. "The launch of calcipotriene cream further demonstrates our commitment to improving patient access to high-quality, affordable medicines."
US sales for the branded version of calcipotriene cream were approximately $118.8 million for the 12 months ending in May 2012, according to IMS Health.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
