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12:00 AM
Mar 08, 2004
 |  BioCentury  |  Politics, Policy & Law

No decision on 505(b)(2)

Although an appeals court has blocked a bid by Dr. Reddy's Laboratories Inc. to market an altered version of Norvasc amlodipine from Pfizer Inc. before PFE's patent extension expired, the judges left undecided the question of whether NDAs for follow-on products can reference a competitor's safety and efficacy data under section 505(b)(2) of the Food, Drug and Cosmetic Act.

In its ruling on Feb. 27, the U.S. Court of Appeals for the Federal Circuit (CAFC) denied RDY the right to market its Amvaz amlodipine maleate before expiration of a patent extension on Norvasc, the blockbuster hypertension drug formulated as amlodipine besylate. But the decision focused entirely on how different salts or formulations of an active ingredient should be treated under the patent restoration provisions of the...

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