US NEW PRESCRIPTI0N DRUG SALES IN 1991

The leading new prescription pharmaceutical product in the USA last year was Wyeth-Ayerst's non-steroidal anti-inflammatory drug Lodine (etodolac), which received Food and Drug Administration approval on January 31 1991 and achieved prescription volume of over 200,000 in its fourth month on the market, according to the industry Year-End Review for 1991, published by Pharmaceutical Data Services.

Other than Lodine, only four other newly-approved prescription drugs made any significant impact during the year, reported PDS. These were Ortho's Floxin (ofloxacin), Sandoz' DynaCirc (isradipine), Abbott's ProSom (estazolam) and Roerig's Cardura (doxazosin).

The FDA approved 30 New Molecular Entities in 1991, compared with a total of only 23 in both 1990 and 1989, but the year was, nevertheless, not a good one for new prescription products, according to Patrick Miller, vice president for marketing and product development at PDS. All five of the year's top new drugs had been approved by the FDA with an 1C (little or no therapeutic gain) classification, and only five new products approved during the year were awarded an 1A (important therapeutic gain) classification. Of these, Genzyme's Ceredase (alglucerase), approved for Gaucher's disease, Berlex's Fludara (fludarabine), for the treatment of B-cell chronic lymphocytic leukemia, and Parke-Davis' Nipent (pentostatin), approved for hairy cell leukemia, are for the treatment of diseases with small patient populations.