Happi Staff10.27.20
The US Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA granted the approval of nonprescription Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice infestations in patients 6 months of age and older to Arbor Pharmaceuticals LLC.
The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.
“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”
Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.
With the switch, Sklice will be marketed in the US as a nonprescription drug and will no longer be available as a prescription drug.
Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective when used as directed in the proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional, noted FDA.
In the US, it is estimated that between 6 and 12 million cases of head lice infestation occur each year in children 3 to 11 years of age, according to the U.S. Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children and members of a household where children have lice.
The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.
Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.
With the switch, Sklice will be marketed in the US as a nonprescription drug and will no longer be available as a prescription drug.
In the US, it is estimated that between 6 and 12 million cases of head lice infestation occur each year in children 3 to 11 years of age, according to the U.S. Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children and members of a household where children have lice.
