The UK's Medicines and Healthcare products Regulatory Authority (MHRA) has issued a pharmacy license to Iceland-based generic drugmaker Actavis' Clamelle azithromycin 500mg antibiotic tablets for the treatment of the sexually-transmitted genital infection, asympotmatic Chlamydia trachomatis. The move comes only a week after the UK government issued a warning against the overuse of antibiotics due to concerns about drug resistance. However, the MHRA insists that the nature of the treatment, two tablets taken in a single dose, as well as assurances from the manufacturer to monitor usage, are sufficient to overcome any concerns about the long-term efficacy of the drug. All other preparations involving azithromycin remain under prescription-only dispensation.
Sara Vincent, the country manager for Actavis UK, said: "we are delighted to have been granted a pharmacy license for Clamelle." She added that the successful application is in line with the firm's program of switching from prescription-only medicine (POM) status to pharmacy only (P). Pharmacists will be provided with training materials and launch details about the medicine, as well as a Clamelle-branded chlamydia testing kit.
The National Pharmacy Association described the move as "an unparalleled opportunity for community pharmacy to become an alternative option for safe and effective treatment for chlamydia infection." The group explained that there is a gap in the current provision of chlamydia screening and treatment that the Actavis product will help to fill. Anonymized patient data from pharmacies will be used by the National Health Service and the National Chlamydia Screening Programme to develop a more comprehensive demographic picture of the disease's distribution.
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