ucm054809 - DEPARTMENT OF HEALTH HUMAN SERVICES Public...

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.

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.