Carafate maintenance claim
Marion Merrell Dow's application for use of its ulcer drug for maintenance therapy of healed duodenal ulcers recently gained "approvable" status at FDA. Carafate is approved for short-term (up to eight weeks) treatment of duodenal ulcers.
You may also be interested in...
The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?
Lorbrena is approved as a second-line treatment for ALK-positive NSCLC but Pfizer believes data from the first-line Phase III CROWN study makes the drug a serious competitor to standard of care Alecensa in the first-line setting.