10 May 2019 - Deborah Wilkes
Galderma is seeking to switch two medicines containing benzoyl peroxide – Acnecide Face Gel and Acnecide Face Wash – from pharmacy (P) to general-sale list (GSL) status in the UK.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has just launched a public consultation on the proposed switches.
The regulatory agency says the GSL versions would have more limited conditions of use than the current P medicines called Acnecide Gel and Acnecide Wash. Galderma intends to keep the P medicines which can be used for more severe acne on any part of the body.
Consultation document ARM98 says the UK's Commission on Human Medicines (CHM) has advised that the two medicines containing 5% w/w benzoyl peroxide can be given GSL status. They would be indicated for treatment of mild acne affecting the face in adults and adolescents aged 12 years and over.
Status of benzoyl peroxide in UK
ARM98 points out that the safety of benzoyl peroxide is well established. "It has been prescribed for topical treatment of acne since the 1960s," says the consultation document, adding "products containing this active ingredient are available in 70 countries worldwide".
In the UK, Acnecide Gel was approved as a P medicine in 1992, and Acnecide Wash Gel was approved as a P medicine in 2002.
ARM98 says Acnecide Face Gel and Acnecide Face Wash would be the first products containing benzoyl peroxide to be available as GSL medicines in the UK.
Existing GSL medicines for topical treatment of spots or acne contain active ingredients such as nicotinamide, chlorhexidine gluconate and zinc oxide. In addition, traditional herbal products containing tea tree oil are available.
Acnecide Face Gel would be available in a 15g pack while Acnecide Face Wash would be available in a 50g pack.
Comments should reach the MHRA by 30 May 2019.
Galderma is part of Nestlé's Skin Health business. Nestlé recently announced that it had entered into exclusive negotiations on the sale of its Skin Health business for CHF10.2 billion (USD10.1 billion) to a consortium led by private-equity firm EQT and the Abu Dhabi Investment Authority (ADIA) (click here to read the News story).
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