Soolantra (ivermectin) cream, 1% is indicated for the treatment of inflammatory lesions of rosacea.
Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski said, "This is the Rx team's fifth generic product approval this month. This tentative approval further illustrates our commitment to advancing our new product pipeline and providing savings to patients and healthcare systems."
Perrigo manufactures over-the-counter (OTC) healthcare products and supplies infant formulas for the store brand market, as well as producing "extended topical" prescription drugs. The company sells its products primarily in North America and Europe, as well as in Australia, Israel, and China.
Mabwell's clinical trial application for 9MW5211 cleared by US FDA
Specialised Therapeutics' chronic graft-versus-host disease therapy approved in Australia
GSK secures US and EU fast-track designations for efimosfermin in MASH
AstraZeneca reports third positive Phase III trial for tozorakimab in COPD
GSK strengthens pulmonary hypertension pipeline with USD950m acquisition of 35Pharma
Mestag Therapeutics to present targeted LTBR agonist MST-0312 at AACR Annual Meeting
Trellus Health renews licensing agreement with Pfizer
EU approves Sanofi and Regeneron's Dupixent for young children with chronic spontaneous urticaria
GSK secures China approval for Exdensur to treat nasal polyp condition
Insmed reports Phase 2b study of brensocatib did not meet efficacy endpoints
Alloy Therapeutics and Biogen expand partnership with multi-target antisense collaboration
Innovent and Ollin Biosciences report IBI324 study data in wAMD and DME