Glenmark receives MHRA, UK approval for Maloff Protect

Maloff Protect is the first OTC approval granted by MHRA, which will be used for the prevention of malaria in adults

Glenmark has been granted final approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for Maloff Protect (250mg/100mg atovaquone/proguanil film-coated tablets), anti-malarial medication, as a pharmacy license in the UK.

Maloff Protect will be used in the prevention of malaria in adults travelling to areas where malaria is prevalent. Maloff Protect contains atovaquone and proguanil hydrochloride, and has been available only as a prescription medicine in the UK. Under this approval, patients will be able to purchase Maloff Protect without a prescription.

Achin Gupta, Executive VP & Business Head Europe, Glenmark Pharmaceuticals said, “The launch of Maloff Protect as an OTC product is a significant development for the UK and our entire European business. This is our first major OTC launch in the UK. We are glad that the MHRA, UK has granted us the pharmacy license and thus making the product accessible to millions of citizens who visit countries where malaria is prevalent. The launch also marks our entry into the OTC segment primarily through the pharmacy chains. We will continue exploring this route to grow the business.”