This article is more than 5 years old. Information may no longer be current.
FDA tentatively approves pediatric HIV-1 treatment
Click Here to Manage Email Alerts
Mylan today announced it has received tentative FDA approval for a fixed-dose combination of abacavir and lamivudine to treat HIV-1 among children.
Two dosages received tentative approval, 60 mg/30 mg and 120 mg/60 mg for oral suspension. Both treatments are indicated for use in combination with other pediatric antiretroviral treatments. This is the first version of an abacavir/lamivudine combination with scoring that allows for dose adjustment, according to a press release. The product is expected to be available for purchase in early 2015.
“The new, flavored dispersible medication will help meet the needs of over 500,000 children being treated for HIV in low- and middle-income countries,” David Ripin, PhD, executive vice president and chief scientific officer of Clinton Health Access Initiative, said in the release.
Heather Bresch
In 2012, Mylan, Clinton Health Access Initiative and ViiV Healthcare reached an agreement to provide technology and resources necessary to facilitate regulatory authority submission, production and distribution of the treatment to 115 resource-limited countries at a low cost. The FDA approval allows for further development of that agreement.
“This new pediatric drug formulation is designed to help parents and caregivers give accurate doses of the medication depending on the weight of the child,” Heather Bresch, Mylan CEO, said in the release.