1. Biogen Corp. came a step closer Monday to getting its drug beta interferon to market when it formally filed a new drug application for Food and Drug Administration approval. 2. A few weeks ago, lukewarm support from AIDS activists helped torpedo a drug application from Gilead Sciences of Foster City, Calif. 3. Abbott said it would gather data and submit a new drug application quickly. 4. Chantal turned around and filed an investigational new drug application with the FDA. 5. Duramed said it had filed with the Food and Drug Administration to begin the clinical tests required before filing a new drug application. 6. Glaxo-Wellcome filed a new drug application in March for Advair Diskus, an inhaler that combines a long-acting bronchodilator with a corticosteroid. 7. Instead, abbreviated versions of new drug applications would have to be submitted to show that the companies could consistently make drugs that held their potency for six months. 8. Interneuron Pharmaceuticals Inc., today announced it has filed a new drug application with the Food and Drug Administration to sell its CerAxon for preventing certain strokes. 9. It has held drug toxicity workshops for staff members who review new drug applications. 10. Lilly filed a new drug application with the FDA for olanzapine in September. |