Viagra Clears Hurdle to EU Approval; Go-Ahead Seen on Sept. 15
Bloomberg News
August 25, 1998, 6:25 a.m. ET
Viagra Clears Hurdle to EU Approval; Go-Ahead Seen on Sept. 15
Brussels, Aug. 25 (Bloomberg) -- Pfizer Inc.'s Viagra is
set to get marketing approval in the 15-nation European Union,
as long as the blockbuster impotence drug carries a clearer
label about its side effects, the European Commission said.
A committee of drug experts from EU governments recommended
authorizing the sale of Viagra once Pfizer, the second-largest
U.S. drugmaker, more clearly spells out the ''undesirable side
effects'' on the label, the commission said. It scheduled the
final approval for Sept. 15.
The scrutiny of the world's best-selling impotence
treatment coincides with an international conference on the
ailment in Amsterdam this week, attended by representatives of
Pfizer, Pharmacia & Upjohn Inc., Astra AB and other companies
involved in the market for such drugs.
Viagra got the backing of the European Medicines Evaluation
Agency, an expert panel that advises European regulators on drug
approvals, on May 29.
Viagra became one of the best-selling U.S. drugs within
weeks of its April introduction, and black-market sales have
been reported around the world. EU residents have been traveling
to buy Viagra in non-EU countries such as Andorra and
Switzerland, where it is already licensed for sale.
Pfizer said it could start selling Viagra in 50 countries
by the end of the year if it wins EU approval.
Viagra won approval from the U.S. Food and Drug
Administration in March. The FDA said last month 39 men taking
Viagra had died, but a link to the drug hasn't been established.
--Alison Jahncke and James G. Neuger in the Brussels bureau (32
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