The approval was supported by data from ARRIVAL (N=25), an ongoing Phase 3 open-label safety study in children with CF aged 12 to <24 months with 1 of 10 CFTR gene mutations (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H).
Currently, the Advisory Committee on Immunization Practices (ACIP) recommends pregnant women receive the Tdap vaccination to prevent pertussis infection.
The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).
Caregivers of hospitalized children had median nonmedical expenses and lost wages totaling $51.4 per day of hospitalization.
The 7 treatments included in the study were amphetamines (including lisdexamfetamine), atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil.
Jornay PM utilizes the proprietary Delexis drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day.
The NDA included safety and efficacy data from 2 randomized, multicenter, double-blind, placebo-controlled trials in patients aged ≥12 years with seasonal allergic rhinitis (N=2352).
For patients unable to swallow an intact capsule, the pellets can be sprinkled over soft food (eg, applesauce, yogurt, pudding) or given via a nasogastric (NG) tube.
The researchers found that in children who had been breastfed, there was a correlation for increased or riskier wave 1 maternal alcohol consumption with reductions in Matrix Reasoning scores at age 6 to 7.
Young children or inexperienced swimmers should be within arm's reach of an adult, while older children should swim with a partner. Lastly, US Coast Guard-approved life jackets should be used in and around open water.
Organizations representing over 700,000 women and adolescent health care providers, including the ACOG, the AAP, and the American College of Physicians, are opposing all efforts to limit medically accurate health care information available to patients and exclude qualified providers from participating in the Title-X program.
Compared with child-targeted products without a GF claim, child-targeted GF products had lower levels of sodium, total fat, and saturated fat, and also had less protein, and a higher percentage of calories from sugar.
These results challenge existing conceptions that omega-3 fatty acids may be effective in treating adolescent major depressive disorder.
Previously, the product was approved for growth failure in children due to inadequate endogenous growth hormone (GH) secretion and for the replacement of endogenous GH in adults with GH deficiency.
The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.
Like Sabril, Vigadrone carries a Boxed Warning regarding the risk of permanent vision loss and is only available to healthcare professionals and patients under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program
Discussions involving Internet challenges with children and adolescents should be as sensitive as those about sexuality and drug or alcohol use.
"These children don't have to die," KidsAndCars.org founder and president Janette Fennell said in a statement. "Parents and caregivers have the power to make sure that this doesn't happen to them."
The retrospective cohort study involved a search of Medicaid claims of pediatric patients aged 5 to 20 years who were initiated on atypical antipsychotic medications.
CUTX-101, a subcutaneous injectable formulation of copper histidinate, is designed to supplement blood and brain copper levels in patients with Menkes disease.
The approval was supported by Phase 3 data from the ATMOS-1 and ATMOS-2 trials which evaluated the absolute change from baseline in sweat production after treatment with Qbrexza, and the proportion of patients who achieved ≥4-point improvement from baseline in their sweating severity (as measured by the Axillary Sweating Daily Diary [ASDD]).
By testing type, detection rates were 32.6% for the epilepsy-related gene panel, 44.8% for the clinical WES gene panel, and 17.3% for WES.
In 2017, a Work Group was assembled to conduct a systematic review of 3HP regimen studies published between January 2006 to June 2017, specifically looking at outcomes in children, individuals with HIV/AIDS, and those who self-administered treatment.