The Canadian government has approved Upjohn Co.'s patented remedy for baldness, and the drug will be introduced on the market by early next month, company officials said today.
Upjohn has an application for Rogaine Topical Solution, formerly called Regaine, a drug for male pattern baldness, pending before the Food and Drug Administration and before regulatory agencies in more than a dozen foreign nations, company spokesman T. R. Reid said.
“The approval by Canada is the first for Rogaine, and obviously we’re pleased by that,” Reid said, noting that although the drug was approved for use in Guatemala earlier this year, the Canadian action was considered the first major approval for the compound.
He said Rogaine will not be introduced for sale in Guatemala before its debut in Canada. Reid said Upjohn officials consider it unlikely that the Canadian government’s approval will influence other governments being asked to approve the drug.
FDA Is ‘Expeditious’
“Regulatory agencies in various countries are independent bodies,” he said. “We think the FDA has been expeditious in their review (of Rogaine) to this point, and we’re hopeful they’ll continue to perform in that way.”
Reid said Rogaine, which is applied externally, will be available in Canada only with a prescription and should be used only under a doctor’s supervision.
He declined to speculate how much the product will post in sales, but industry analysts have predicted that Rogaine could represent up to $1 billion in annual sales on a worldwide basis.
Upjohn research in 1983 and 1984 into the treatment of male pattern baldness with Rogaine revealed that 76% of 619 patients in a group that received a 2% solution of the drug experienced hair growth during the yearlong study. Of those who experienced hair growth, 40% described it as moderate and 8% said it was dense.