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14/05/2004| Angelini launches a new antibacterial drug on the market

The Angelini ACRAF S.p.A. pharmaceutical company has announced the launch on the market of a new medicinal product containing prulifloxacin, with the Unidrox brand, indicated for the treatment of infections of the respiratory tract (acute or chronic bronchitis)  and the urinary tract (simple or complicated cystitis).

Prulifloxacin is a drug belonging to the fluoroquinolone antibacterial agents class,  discovered and developed by the  Japanese pharmaceutical company Nippon Shinyaku. Since 1993 Angelini  has been the European holder of the prulifloxacin licence and has developed the product in its laboratories.

Angelini has made licence agreements with the Keryos S.p.A. and the Società Prodotti Antibiotici companies, which market two products containing prulifloxacin in Italy, registered with the brands Keraflox® and Chinoplus® respectively. Angelini ACRAF has received authorisation from the Ministry of Health for marketing Unidrox® by A.I.C. (marketing authorisation) decree no. 312 of 21 June 2004, published in the Official Gazette no. 230 of 30/9/2004. The Ministry also issued a marketing authorisation for the Keraflox ® (A.I.C. decree no. 310 of 21/6/2004) and Chinoplus ® (A.I.C. decree no. 311 of 21/6/2004) brands.

After registering the brand, Angelini  started the abridged procedure for mutual recognition in the European Union. The sublicensees for the promotion and sale of prulifloxacin are Recordati S.p.A. and RottaPharm Spain, for Spain, and Laboratòrios Delta Lda, for Portugal. Pending completion of the registration process in these countries, Unidrox ® will be marketed in Spain by Farma Lepori S.A. and in Portugal by Angelini Farmacêutica Lda.

Angelini has been active for more than eighty years in putting science at the service of the wellness of people. With Unidrox it developed a highly tolerable antibiotic drug with a wide spectrum of action in its research laboratories. Moreover, Unidrox is particularly indicated for the female public because it does not harm the vaginal bacterial flora, and for the elderly because it is the first drug of its class that can be administered only once a day.

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