JUNOMINE ER, PHENTERMINE JUNO ER (Juno PC Holdings Pty Limited)
Product name
JUNOMINE ER, PHENTERMINE JUNO ER
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 working days (255)
Active ingredients
phentermine hydrochloride
Registration type
New generic medicine
Indication
JUNOMINE ER, PHENTERMINE JUNO ER (extended release tablet) is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater.
The treatment with Phentermine can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine