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Executive Summary

LYPHOMED SEEKING ANDA ROUTE FOR METHOTREXATE in pharmacy bulk packaging for use in large cancer treatment centers. In a Sept. 4 petition, the firm asked FDA to declare that 1,000 mg methotrexate sodium injection, USP, 25 mg/ml in a 50 ml vial is ANDA suitable. LyphoMed asserted that its methotrexate dosage is identical to Lederle's parenteral methotrexate, which is listed as ANDA suitable, and has advantages over the currently marketed 20, 50, 100, 200 and 250 mg vials. LyphoMed said the pharmacy bulk package offers "ease of administration by the pharmacist in preparation of large numbers of syringes, for direct infusion, from a single multi-dispensing device." In addition, such a dosage form eliminates "the manual repetitive motion of entering numerous vials, and aerosolization of chemotherapy liquid by creating a closed system which would assure dispensing safety," LyphoMed stated. In a busy oncologic center, LyphoMed declared pharmacists "may enter up to 250 vials of methotrexate monthly, raising a major safety concern in handling antineoplastic drugs." The firm asserted that "if any of the methotrexate remains in the neck of the vial and there is positive pressure build-up during dispensing, then manual entering of the vials could cause aerosolization of the chemotherapeutic agent. In this given situation, the risk to the pharmacist is multiplied by 250." The firm pointed out that ANDAs for aminophylline injection and potassium chlor- ide injection have previously been found suitable by FDA for a pharmacy bulk package. LymphoMed said the dispensing procedure for the methotrexate container is identical to these two products: "a single dose container without preservatives ]that has its[ contents drawn in a single dose and subsequently added to multiple-patient IV solution."

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