ucm054809 - DEPARTMENT OF HEALTH & HUMAN SERVICES...

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Elizabeth M. Zola, Pharm.D. Associate Director, Regulatory Affairs Ross Products Division Abbott Laboratories 625 Cleveland Avenue Columbus, OH 43215-1724 Re: NDA # 20-032 Survanta ® (beractant) intratracheal suspension MACMIS # 13536 Dear Dr. Zola: The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a professional direct mailer (C1362C/4040) for Survanta ® (beractant) intratracheal suspension (Survanta) submitted by Ross Products Division, a division of Abbott Laboratories (Abbott) under cover of Form FDA 2253. This direct mailer is false or misleading because it makes unsubstantiated effectiveness claims for Survanta and minimizes the risks associated with the drug, and, therefore, misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. §§ 352(a), 321(n). Background Survanta is a pulmonary surfactant made from natural bovine lung extract. According to its PI, SURVANTA is indicated for prevention and treatment ("rescue") of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications. Prevention In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within 15 minutes of birth. Rescue To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.
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Elizabeth M. Zola, Pharm.D. Page 2 Abbott Laboratories NDA 20-032 Survanta has no known contraindications, but has a number of important risks. For example, the WARNINGS section of the PI states, SURVANTA is intended for intratracheal use only. SURVANTA CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. DURING THE DOSING PROCEDURE, TRANSIENT EPISODES OF BRADYCARDIA AND DECREASED OXYGEN SATURATION HAVE BEEN REPORTED. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure. Furthermore, the PRECAUTIONS section states,
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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ucm054809 - DEPARTMENT OF HEALTH & HUMAN SERVICES...

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