THE US Food and Drug
Administration (FDA) has granted
approval for Differin Gel 0.1%
(adapalene), a once-daily topical
gel which contains the first new
active ingredient for over-the-counter
acne use since the 1980s.
Differin Gel is a retinoid, and
was originally approved in 1996
as a prescription product for the
treatment of acne vulgaris in
patients 12 years of age and older.
Distributed by Galderma
Laboratories, the OTC approval
was supported by data on post marketing
safety accrued over
the last 20 years, along with data
from consumer studies and from a
maximal use trial.
FDA deputy director Lesley
Furlong said with millions of acne
sufferers, “now consumers have
access to a new safe and effective
over-the-counter option”.
Differin Gel was TGA-approved
in in 1995 and is currently listed as
Schedule 4 (prescription only).The above article was sent to subscribers in Pharmacy Daily's issue from 11 Jul 16 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 11 Jul 16
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