Navigation Links
FDA Approves Head Lice Treatment for Children and Adults
Date:1/18/2011

SILVER SPRING, Md., Jan. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.  

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Head lice are parasitic insects found on people's head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice.  Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

"Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Head lice is a common problem among school children in the United States."

Natroba is a topical drug product and should be applied only to the child's scalp or hair.  The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.  

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol.   Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.  

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

For more information:

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain
2. VIDEO from Endo Pharmaceuticals Available on thenewsmarket.com: FDA Approves New Treatment for Low Testosterone
3. FDA Approves New Dosage Strength for INTELENCE®
4. U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
5. FDA Approves PREZISTA®/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
6. FDA Approves New Manufacturing Facility for Collagenase SANTYL® Ointment
7. Vermillion Reappoints Three Directors, Approves a New Stock Incentive Plan, and Ratifies PricewaterhouseCoopers LLP as Its Accounting Firm
8. FDA Approves Xgeva to Help Prevent Cancer-Related Bone Injury
9. FDA Approves New Treatment Option for Late-Stage Breast Cancer
10. FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
11. FDA Approves Cymbalta® for the Management of Chronic Musculoskeletal Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., ... vaccine design, and immune-engineering today announced the launch ... the development of personalized therapeutic cancer vaccines. EpiVax ... provided exclusive access to enabling technologies to the ... MBA will lead EpiVax Oncology as Chief Executive ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed ... geared towards children of all ages; it is a non-competitive, non-timed event, which is ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... ... 12, 2017 , ... Planet Fitness, one of the largest and fastest growing ... open a flagship location in Covington, LA at 401 N. U.S. Highway 190, in ... to Office Depot in the Holiday Square shopping center. Its location allows it to ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s ... the 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, ...
Breaking Medicine News(10 mins):