Genelabs Prestara “approvable”
Executive Summary
Genelabs plans to meet with FDA to discuss additional study for lupus treatment Prestara (prasterone) (formerly Aslera), following receipt of "approvable" letter Aug. 28. Approval is contingent upon study confirming positive effect on bone mineral density in women with mild to moderate systemic lupus erythematosus while on low-dose glucocorticoids. The product was deemed "not approvable" June 26, 2001 (1"The Pink Sheet" July 2, 2001, p. 16). Prestara will be marketed by Watson...
You may also be interested in...
Genelabs Requests Meeting With FDA After Aslera "Not-Approvable" Letter
Genelabs plans to meet with FDA to discuss the NDA for its lupus treatment Aslera (prasterone) following receipt of a "not-approvable" letter June 26.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.