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Home Industry News Alcon submits NDA amendment for Patanase

Alcon submits NDA amendment for Patanase

11th October 2007

Alcon has submitted an amendment to the pending new drug application (NDA) for its nasal spray Patanase.

The US Food and Drug Administration (FDA) initially received the NDA for the treatment of symptoms of seasonal allergic rhinitis in those 12 years of age and older.

The new amendment now includes interim six-month data which was requested by the FDA to support an alteration to the formulation of Patanase nasal spray.

Dr Rohit Katial, a principal investigator for Patanase, expressed his delight in working closely with the FDA to demonstrate the benefits of the nasal spray.

“Data collected through multiple studies that make up the current NDA demonstrate that Patanase provides rapid relief from bothersome nasal allergy symptoms.”

Patanase uses the same active ingredient as Alcon’s selection of products for ocular allergies – olopatadine hydrochloride.

This compound, in its nasal formulation, has shown efficacy in the treatment of symptoms relating to seasonal allergies when investigated in clinical trials.

Last month, Alcon announced that it had amended its tender offer for WaveLight, with the firm announcing an extension of its offer and the waiver of the 75 per cent threshold of its minimum tender offer acceptance.

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