Filing For Supplement To Albuterol ANDA
Medeva reported at its annual results presentation in London that clinical studies for its generic albuterol metered-dose inhaler (MDI) Abbreviated New Drug Application in the USA have now been finalized, and the supplement to the ANDA filing will be submitted in April.
The company anticipates an approval for the drug this year, and accordingly has installed additional capacity at its manufacturing plant to cope with the increase in production required.
Also detailed at the meeting, the company outlined its progress with some of its other late-stage products. The most exciting of these, said the firm, is the Hepagene hepatitis B vaccine. Preliminary results from the product (Marketletter March 6) were encouraging and Hepagene will enter further trials this year, with a filing for a European product license scheduled for the end of 1996.
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