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Leucovorin calcium ANDA suitability petitions

Executive Summary

Burroughs-Wellcome asked FDA for permission on file an ANDA for a 100 mg sterile powder version of Lederle's 50 mg injectable. B-W already markets Wellcovorin liquid and tablets. Besides proposing a higher strength, B-W proposed to deviate from Lederle's labeling by borrowing from the Wellcovorin tablet labeling the clinical pharmacology, indications and usage, contraindications, warnings, precautions, overdosage, and dosage and administration sections. Wellcovorin labeling "contains the most up-to-date prescribing information [and] a better presentation of content and format," the firm said. In addition, Quad Pharmaceuticals asked to submit an ANDA for a 10 mg/ml, 5 ml sterile fill solution, and David Bull Labs, Ltd. proposed an ANDA for a 10 mg/ml concentration.

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