Magazine article Drug Topics

Estrogen ANDA Battle Heats Up over APhA Stand

Magazine article Drug Topics

Estrogen ANDA Battle Heats Up over APhA Stand

Article excerpt

The battle lines have been drawn over an application for a generic version of Premarin that finds the American Pharmaceutical Association supporting Wyeth-Ayerst Laboratories' efforts to persuade the Food & Drug Administration to reconsider, while others see political clout being wielded.

Opinions are divided on the Abbreviated New Drug Application filed by Duramed Pharmaceuticals for a generic Premarin, which does not contain Delta 8,9 DHES because the FDA's 1991 bioequivalence standards deem it merely an impurity in the branded conjugated estrogen product. In answer, Wyeth-Ayerst filed a citizen petition with the FDA last fall to get a reversal of the agency's stance so that Delta 8,9 DHES would be required for an AB-rated generic.

In a recent letter to FDA commissioner David Kessler, APhA executive v.p. John Gans urged postponement of action on the ANDA and requested that Wyeth-Ayerst conduct research into the clinical significance of all the active components of Premarin. He warned against forcing pharmacists to dispense a generic product in which they have little confidence and against setting a dangerous precedent for the FDA.

Pharmacists Planning Service Inc., on the other hand, is prepared to take the FDA's word that the generic Premarin is bioequivalent--if the agency will put it in writing. "Our thinking right now is that if the FDA says the drugs are interchangeable, let's lower the cost to patients and go with the generic," said Fred Mayer, who heads the Sausalito, Calif. …

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