Canada gives nod to acne indication for OC
The oral contraceptive (OC) Tri-Cyclen, manufactured by Ortho-Janssen of Toronto, Ontario, has been approved by the Canadian regulatory agency Health Canada as an effective treatment for acne in women seeking contraception.
The OC is the first low-dose birth control pill approved for a noncontraceptive indication in Canada. The Canadian endorsement follows a similar nod in 1997 from the U.S. Food and Drug Administration (FDA) for Ortho Tri-Cyclen, which is manufactured by the American affiliate Raritan, NJ-based Ortho Pharmaceutical Co. (For information on the FDA approval, see Contraceptive Technology Update, March 1997, p. 25.)
Tri-Cyclen combines a constant dose of 35 mcg of the estrogen ethinyl estradiol with a graduated dose of the progestin norgestimate for its effectiveness. Originally released in Canada in 1993, it is too early to tell the impact the new indication will have on the market, says company spokesman Walter Masanic.
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