Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Tuesday the receipt of tentative approval from the US Food and Drug Administration (FDA) for the generic version of Picato Gel (ingenol mebutate) 0.015% indicated for the topical treatment of actinic keratosis.
This US FDA submission date of the company's abbreviated new drug application matches the first-to-file date on the FDA's Paragraph IV Patent Certifications list.
For the 12 months ending August 2017, the branded market sales were approximately USD51m, added the company.
An actinic keratosis (AK), also known as a solar keratosis, is a crusty, scaly growth caused by damage from exposure to ultraviolet (UV) radiation. AK is considered a precancer because if left alone, it could develop into a skin cancer, most often the second most common form of the disease, squamous cell carcinoma (SCC).
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
International Isotopes Inc to change name to Radnostix Inc
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream