GlaxoSmithKline’s acne treatment Fabior has been given the green light by regulators in the USA.
The US Food and Drug Administration has approved GSK unit Stiefel’s Fabior (tazarotene) foam, 0.1%. The company noted that it is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients aged 12 and older.
The approval is based on two Phase III studies and GSK noted that the foam is contraindicated in pregnancy and may cause foetal harm when administered in pregnant women. Acne affects 40–50 million Americans at any one time.
GSK bought Stiefel in July 2009 for an initial $2.90 billion. At the time, it was the world’s largest private manufacturer of dermatology products and had annual sales of around $900 million.
