The U.S. Food and Drug Administration has given permission to Indian generic-drug maker Lupin Ltd. to seek approval for a generic version of Pfizer Inc.'s blockbuster cholesterol drug Lipitor with a different formulation than the original drug.
The FDA decision, however, isn't likely to result in the introduction of the Lupin product anytime soon. Lupin still must go through the normal generic-drug approval process before it can launch its proposed capsule version of Lipitor--the original product is a tablet--and agency reviews can take upwards of two years.
Lipitor's impending loss of U.S. market exclusivity will be a major financial blow to Pfizer, which has cut costs and diversified its business lineup in preparation.
In 2008, Lupin filed a citizen petition with the FDA asking for permission seek approval of the capsule version of Lipitor. Lupin said it wanted to market a capsule version for people who have difficulty swallowing a tablet or prefer a capsule form.
The FDA last week granted Lupin's request, according to a letter posted online by the agency. The agency said Lupin's proposed capsule version of Lipitor wouldn't pose questions of safety or effectiveness, since the uses and oral route of administration are the same as the original tablet.
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