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:2/10/2016)... , Feb. 10, 2016  Resolve Therapeutics, ... transformative new approaches to the treatment of lupus ... of a multiple ascending dose study in patients ... compound RSLV-132. --> ... placebo-controlled multiple ascending dose study of RSLV-132 in ...
(Date:2/10/2016)...  Rich Pharmaceuticals, Inc. (OTC Markets: RCHA) ("Rich Pharmaceuticals" ... of its issued and outstanding shares of common stock ... 11, 2016. The Company,s common stock will trade on ... temporary ticker symbol "RCHAD". After 20 trading days, the ... (RCHA).  --> --> ...
(Date:2/10/2016)... , Feb. 10, 2016  The Baylor ... received an in-kind gift from ... VeinViewer® Vision vein finder for the nursing ... students as they learn how to start ... with traditional technique. ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... Intalere’s ... together more than 200 of the country’s top healthcare executives to share insights ... true benefit of the Forum is the provider-centric perspective, experience, expertise and strategy ...
(Date:2/10/2016)... ... February 10, 2016 , ... Armune BioScience signed a ... network of laboratory service centers across the country. Launched in April of 2015, Apifiny ... detection of prostate cancer. Apifiny order volume exceeded 3,000 tests in 2015. Primary care ...
(Date:2/10/2016)... ... February 10, 2016 , ... A ... Ohio Safety Congress and Expo event March 9-11, 2016. Hosted by Ohio's Bureau ... Center. , As the longest running and largest worker's compensation event in ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... 1 UNF Drive, Jacksonville, FL 32224, February 26th: Amateur & Professional Divisions ... Division - Time: 7:00pm – 10:00pm | Ticket Prices $30, Social Media: ...
(Date:2/10/2016)... ... February 10, 2016 , ... Anxiety of older Americans ... start of Medicare Part D a decade ago, according to The Senior Citizens ... adults on how they are coping with rapidly rising costs. “The implications are ...
Breaking Medicine News(10 mins):