Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) (The San Francisco Examiner)
BRIDGEWATER, N.J. ( Map ) - BRIDGEWATER, N.J., March 7 /PRNewswire/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT(R) (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.

ActivBiotics Receives FDA Orphan Drug Designation For Superoxide Dismutase Mimetic, M40403, In Oral Mucositis Of Cancer (Medical News Today)
Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation for M40403 for the prevention of radiation -- or chemotherapy -- induced oral mucositis (OM) in cancer patients.

CORRECTION: Pipex Pharmaceuticals' Oral Flupirtine IND With FDA for Phase II Clinical Trial for Fibromyalgia Not Yet ... (Marketwire via Yahoo! Finance)
This press release amends and replaces the press release titled, "Pipex Pharmaceuticals' Oral Flupirtine Opens IND With FDA for Phase II Clinical Trial for Fibromyalgia," of the same date announcing the opening of an investigational new drug application for Pipex's oral flupirtine. This morning, the company has learned from the principal investigator that late Friday, the principal investigator ...