Thursday, March 8, 2012

Surfaxin (Lucinactant) Approved By FDA For The Prevention Of Respiratory Distress Syndrome (RDS) In Premature Infants.

FDA has approved Surfaxin (Lucinactant) for preventing premature infants from the respiratory distress syndrome (RDS).
The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth.

Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants. The other FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant), and Exosurf (colfosceril palmitate), which is no longer marketed.

A single randomized, active-controlled, multi-dose study involving 1,294 premature infants demonstrated the safety and efficacy of Surfaxin. Within 30 minutes of birth, infants in the study received either Surfaxin, Exosurf or Survanta. Surfaxin and Exosurf served as the primary comparison for this study; Survanta served as another comparison. Surfaxin demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through two weeks, when compared with Exosurf.

The most common side effects of Surfaxin are related to its administration down a premature infant’s breathing tube (endotracheal tube) and include endotracheal tube reflux, skin paleness, endotracheal tube obstruction, and need for dose interruption.

Surfaxin is manufactured by Discovery Laboratories Inc. of Warrington, Pa.
Drug Name(s)SURFAXIN (Brand Name Drug)
FDA Application No.(NDA) 021746
Active Ingredient(s)LUCINACTANT
CompanyDISCOVERY LABORATORIES INC
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
SURFAXIN
®
(lucinactant) Intratracheal Suspension is indicated for the prevention of respiratory
distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN reduces the
incidence of RDS at 24 hours and mortality due to RDS.
2 DOSAGE AND ADMINISTRATION
For intratracheal administration only.
SURFAXIN should be administered by or under the supervision of clinicians experienced in
intubation, ventilator management, and general care of premature infants.
2.1 Dosing
The recommended dose of SURFAXIN is 5.8 mL per kg birth weight. Up to 4 doses of
SURFAXIN can be administered in the first 48 hours of life. Doses should be given no more
frequently than every 6 hours.
No information is available on doses greater than 5.8 mL per kg birth weight, the effects of more
than 4 doses, or dosing more frequently than every 6 hours.
Dosage may be determined from Table 1.
Table 1. Dosing Chart
Birth Weight (g) Total Dose (mL)
600-649 3.5
650-699 3.8
700-749 4.1
750-799 4.4
800-849 4.6
850-899 4.9
900-949 5.2
950-999 5.5
1000-1049 5.8
1050-1099 6.1
1100-1149 6.4
1150-1199 6.7
1200-1250 7.0

AeroShot “caffeine inhaler” Warned By FDA For False Or Misleading Labeling And More.


AeroShot “caffeine inhaler”
FDA, the U.S. Food and Drug Administration, warned Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product. FDA told the company that the Agency has questions about the safety of the “caffeine inhaler.” The agency was also concerned about children and adolescents using the product in combination with alcohol.
FDA works to protect consumers and acts very seriously about any problems caused by products it regulates.Consumers who believe they have suffered illness or injury from using AeroShot should also report those events to their regional FDA Consumer Complaint Coordinators. The agency also encourages healthcare providers to report to FDA any adverse events in their patients that are associated with AeroShot.