Dermatologists Challenge New Zealand Easing Of Acne Drug Rules
This article was originally published in PharmAsia News
Executive Summary
Dermatologists in Australia and New Zealand are fighting a decision by New Zealand's Pharmaceutical Management Agency to ease restrictions on who can administer acne drugs. Pharmac issued a ruling to allow general practitioners and not just dermatologists to administer isotretinoin, sold as Roche's Accutane in the United States. Dermatologist groups in Australia and New Zealand termed the drug potentially dangerous and said their members have been cautious about administering it. They expressed concern that general practitioners may not be as aware of the drug's safety problems, but a Pharmac director said it had weighed carefully all information about isotretinoin. (Click here for more
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.