By Tess Stynes
Pfizer Inc. (PFE) said the U.S. Food and Drug Administration
will take three months more than initially expected to review the
pharmaceutical company's application to market a new treatment for
rheumatoid arthritis.
The FDA now is aiming for a decision by Nov. 21.
The extension of the review period beyond an initially targeted
Aug. 21 decision date had been anticipated so the FDA could look at
additional data analyses that it had requested.
In May, an FDA advisory committee voted 8-2 to recommend agency
approval of tofacitinib.
Pfizer and other major drug makers have been aiming to add new
products to replace former top sellers as the industry copes with a
patent cliff.
Pfizer in July reported that its second-quarter earnings rose
25% on lower expenses as the company continued to see sales of
former anticholesterol blockbuster Lipitor slide amid competition
from generic versions.
Shares were down by a penny at $23.90 in recent premarket
trading.
Write to Tess Stynes at Tess.Stynes@dowjones.com
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