Bayer's moxifloxacin slated for fall launch in Germany, first market

Bayer AG has said that it intends to launch its new quinolone antibioticAvelox/Avalox (moxifloxacin) in its first market, Germany, on September 1. The company received approval from the drug regulatory agency, the BfArM, on June 18, said a spokeswoman.

In a statement, the company said that its expects regulatory approval in the remaining 14 European Union countries to be completed in the next five months under the mutual recognition procedure. Bayer adds that the product, which has an estimated annual sales potential of 1.7 billion Deutschemarks ($931.6 million), will be on the market by the end of 2000 throughout the EU and by the first quarter of 2000 in the USA. It was first approved in Mexico last December, but is not yet available in that market.

Avelox, administered once a day, is approved for the treatment of all community-acquired respiratory infections, including acute exacerbation of chronic bronchitis, acute sinusitis, community-acquired pneumonia and uncomplicated skin and skin structure infections. The same dose, 400mg, is approved for all indications and there is no restriction on whether it is administered as a first- or second-line therapy, the Marketletter was told.