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Actavis Reykjavik, Iceland, 6 August 2008 -- Actavis Group, the international generic pharmaceuticals company, welcomes the announcement that a pharmacy licence for azithromycin has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The successful application relates to the pharmacy licence for Clamelle Azithromycin 500mg Tablets.
Actavis UK Ltd applied to switch azithromycin tablets from prescription-only to pharmacy status. Clamelle will be the first oral antibiotic available from a pharmacist without a doctor's prescription.
Clamelle is indicated for the treatment of individuals with confirmed asymptomatic Chlamydia trachomatis genital infection and for the treatment of their sexual partners. The dosage is two tablets taken together as a single dose.
Clamelle will be available for people 16 years and over if they have tested positive for the infection and have no symptoms, and for their sexual partners. Individuals will be able to obtain over the counter (OTC) Clamelle from participating pharmacies following confirmation of diagnosis and a thorough consultation with the pharmacist, and without a prescription from their GP or GUM clinic.
Sara Vincent, Country Manager, Actavis UK "We are delighted to have been granted a pharmacy licence for Clamelle. This successful application is in line with Actavis UK's programme of POM to P switches*, which is running in parallel with the expansion of the OTC brand portfolio through organic growth and strategic acquisitions."
Actavis UK Ltd is now developing pharmacy training materials and launch plans for Clamelle, as well as a Clamelle-branded chlamydia test kit.
*POM to P: Prescription Only Medicine to Pharmacy (OTC).
Actavis Group Hjördís Árnadóttir Director - External Communications Tel: (+354) 535 2300 / 840 7476 E-mail: harnadottir@actavis.com
www.actavis.com
About Actavis Group Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in 40 countries, with 11,000 employees.
Any statements contained in this press release that refer to Actavis' estimated or anticipated future results or future activities are forward-looking statements which reflect the Company's current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.
