Magazine article Drug Topics

No Go

Magazine article Drug Topics

No Go

Article excerpt

FDA rules against generic conjugated estrogens

The most prescribed Rx in the United States won't face generic competition anytime soon. After years of weighing scientific evidence, the Food & Drug Administration has decided that it still doesn't know enough about the complex brew of estrogens made from the urine of pregnant mares that Wyeth-Ayerst began selling as Premarin in 1942. "Until the active ingredients are sufficiently defined, a synthetic generic version of Premarin cannot be approved," said Janet Woodcock, director of the FDA's Center for Drug Evaluation & Research, in a May 5 memorandum.

The decision goes beyond what Wyeth had been seeking in its long campaign to protect a $1 billion a year franchise, sure to grow as millions of female baby boomers continue reaching menopause. Wyeth argued that the delta 8,9 dehydroestrone sulfate in Premarin be recognized as a principal component of conjugated estrogens and required of generics. Earlier the FDA had considered delta 8,9 an impurity, but it now says it's not certain what any of the active ingredients are. …

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