Word: fda
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Dates: during 1990-1999
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...earned the company a total of $14 billion and was the first drug ever to chalk up $1 billion in sales in a single year. But in the late 1980s, anticipating the worst when its Tagamet patent ran out in 1994, SmithKline began conducting clinical trials and seeking FDA approval of an over-the-counter version. The wisdom of that decision became evident when Tagamet sales plummeted from $600 million in 1993 to only $400 million last year after the drug lost its patent protection in May and became vulnerable to competition from less expensive generic varieties...
...Johnson & Johnson/Merck, producer of Pepcid, beat SmithKline to the punch. It won FDA approval of its over-the-counter version, Pepcid AC, and began marketing it in June. Between its introduction and August, when Tagamet HB first appeared in pharmacies, Pepcid AC gained a 22% share of the entire antacid market. "Pepcid had a window of opportunity, and it exploited it well in the marketplace," says Silvermine Consulting's Kelly. "That's an amazing accomplishment." Amazing, and expensive. J&J/Merck and SmithKline are each spending some $100 million in marketing campaigns for their new acid blockers...
...drug in the world and the pride of Britain's Glaxo-Wellcome pharmaceutical stable. Prescribed for 240 million patients around the globe, Zantac last year generated $3.6 billion in sales, $2.1 billion in the U.S. And last month the over-the-counter Zantac 75 received a recommendation from an FDA advisory committee, virtually assuring its imminent approval for sale...
Wurtman says health food stores began selling tryptophan as a nutritional supplement and sold it for 15 years without approval from the Food and Drug Administration (FDA...
...patented the drug, some company would have developed it and it would have needed FDA approval, Wurtman says. Then, when the manufacturer changed to the Japanese company, the FDA would have done new tests on the drug...