India-based generics manufacturer Wockhardt announced on 10 January 2012 that it had received final approval from FDA for marketing a generic version of GlaxoSmithKline’s nasal spray allergy treatment Flonase (fluticasone).
Generic nasal spray approved by FDA
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Posted 20/01/2012
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Wockhardt has received approval for the 50 mg version of the nasal spray, which the company intends to launch immediately.
The formulation is used for the treatment of allergic rhinitis, an allergic inflammation of the nasal airways. It occurs when an allergen, such as pollen, dust or animal dander–particles of shed skin and hair–is inhaled by an individual with a sensitised immune system.
According to IMS Health, the total market for fluticasone in the US is about US$580 million and there are only three other generic versions in the US. According to the press release fluticasone nasal spray is one of the most widely used corticosteroids in treating allergic rhinitis.
The regulatory approval also requires the company to conduct trials. Wockhardt Chairman Dr Habil Khorakiwala commenting on the approval said, ‘we have always endeavoured to develop and market products based on challenging technologies and this approval of a nasal spray is another step in that direction. The product involved development of complex precisely controlled formulation as well as the device for the spray.’
Wockhardt will be manufacturing the nasal spray at its facility in Morton Grave, Illinois, USA, using in-house developed technology.
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