P&U Seeks Approval For Inhaled Nicotine

9 June 1996

Pharmacia & Upjohn has filed a New Drug Application with the US Food and Drug Administration for its Nicotrol Nicotine Inhalation System. Subject to approval by the FDA, the Nicotine Inhalation System, for smoking cessation, will be marketed in the USA by the McNeil Consumer Products arm of Johnson & Johnson.

P&U has recently received approvals for the Nicotine Inhalation System from regulatory agencies in Italy and Denmark for over-the-counter sale. The product will be marketed in Europe under the Nicorette brand, which has been firmly established by P&U. The company expects approvals in other European countries by the end of 1996.

Marketing and product launch plans for the USA and also Europe are currently being finalized and will be announced by the firm "in the near future," according to McNeil.

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