Reclassification of U.K. drug
This article was originally published in The Tan Sheet
Executive Summary
The U.K.'s Medicines and Healthcare products Regulatory Agency says March 4 it will reclassify urinary tract infection drug Cystobid 100 mg (nitrofurantoin) - known in the U.S. as Procter & Gamble's Macrobid - from prescription only status (POM) to pharmacy status (P). The marketing authorization is held by Goldshield Pharmaceuticals, according to MHRA. The agency says prompt access to a doctor to obtain a suitable prescription for uncomplicated cystitis is not always possible, so extension of availability to pharmacies is logical. In addition, MHRA says a pharmacy protocol and patient questionnaire have been established to ensure the correct selection of women for the drug. In June, MHRA said it was seeking comments on whether to move another UTI drug, azithromycin 500 mg, from POM to P status (1"The Tan Sheet" June 25, 2007, In Brief)...