In the PIPELINE
In the PIPELINE
- Orphan Medical Inc. says the FDA has accepted its supplemental new drug application (NDA) for Antizol (fomepizole) Injection for treating methanol poisoning and has granted the application priority review status. The FDA approved fomepizole in December 1997 for use in ethylene glycol (antifreeze) poisoning. This supplemental NDA is based on a study in which 82% of patients with documented methanol poisoning survived after treatment with
fomepizole.
- Aventis Pharma and Transkaryotic Therapies Inc. (TKT) want regulatory approval to market Dynepo, a human erythropoietin co-developed by Aventis and TKT. Applications have been filed simultaneously to the FDA and the European Agency for the Evaluation of Medicinal Products. Aventis wants authorization for subcutaneous and intravenous routes of administration for the treatment of anemia in patients with chronic renal failure (including both dialysis and nondialysis patients) to elevate and maintain red blood cell production. Dynepo is a human erythropoietin produced via use of gene activation technology to insert sequences of DNA into human cells. This activates a portion of the endogenous human gene and stimulates production of gene-activated erythropoietin
(Dynepo).
- The FDA has accepted Aronex’s resubmitted new drug application for its orphan product, Atragen. The retinoic acid product is indicated for acute promyelocytic leukemia (APL) in patients whose therapy with tretinoin is necessary but IV administration is required. In late 1999, the FDA told the company that the data in its submission were inadequate for approval. The new amendment includes additional safety and efficacy data involving 116 APL patients, compared with the original 59.
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