US FDA approves generic versions of diabetes drugR

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US FDA approves generic versions of diabetes drug

By Ori Twersky

WASHINGTON, Jan 25 (Reuters Health) - A variety of generic drugmakers

announced on Friday that they have received final approval from the US

Food and Drug Administration (FDA) to market generic versions of

Bristol-Myers Squibb Company's popular diabetes medication Glucophage

(metformin).

The firms-- Pharmaceuticals, Ivax Corporation, Alpharma Inc., Teva

Pharmaceutical Industries Ltd. and Mylan Laboratories Inc.--are among 11

generic-drug manufacturers that are expected to launch formulations of

metformin. Barr Laboratories and Andrx Corp. have also filed

applications to sell generic forms of the drug. Generic metformin is

expected to sell at an 80% discount from the brand-drug price.

Glucophage is the world's top-selling diabetes medication. The drug

reduces blood sugar levels by curbing production of glucose by the

liver.

Bristol-Myers reported Thursday that sales of its Glucophage franchise,

which includes follow-up drugs Glucovance and Glucophage XR, increased

42% in 2001 to nearly $2.7 billion. But with the approval of the

generics, Bristol-Myers is expected to take a hit on its earnings this

year.

The FDA approval also spells an end to the dispute over whether generic

versions of the drug could be approved.

Bristol-Myers previously attempted to prevent the FDA from approving

generic versions based upon results from recently conducted tests on

children. The brand-name drugmaker argued that the FDA could not approve

any generic versions because those versions would not be allowed to

include labeling regarding the appropriate doses for children.

Ivax said that it would begin distributing its generic versions

immediately.

Alpharma told Reuters Health that it would begin distributing its

version " very shortly. " The FDA approval included clearance of the

company's manufacturing facility and all of the other necessary steps

for distribution, said Alpharma Vice President of Investor Relations

Kathleen Makrakis.

Pharmaceuticals could not be reached for immediate comment.