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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)...

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U.K. consumers will be able to obtain an oral antibiotic for the treatment of chlamydia without a prescription, the Medicines and Healthcare products Regulatory Agency announces Aug. 6. Actavis' Clamelle (azithromycin) will be available to consumers 16 years old and up if they test positive for the infection and have no symptoms, as well as for their sexual partners, MHRA says. Actavis is developing training materials and a formal launch plan for Clamelle's switch from prescription only to pharmacy status, which is similar to behind-the-counter in the U.S. In March, MHRA approved urinary tract infection drug Cystobid 100 mg (nitrofurantoin) - Procter & Gamble's Macrobid in the U.S. - for pharmacy sale in a move consistent with the agency's plan to move more POM products into the P class to reduce health care costs, promote self-care and expand the role of pharmacists in treatment (1"The Tan Sheet" March 10, 2008, In Brief and 2"The Tan Sheet" June 6, 2005, p. 4)...

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