Generic Diabetes Drug Given Conditional OK
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Generic drug maker Ivax Corp. said it has received conditional approval from U.S. regulators to sell copycat forms of Glucophage, the world’s top-selling diabetes medicine.
Miami-based Ivax said it won approvable status from the Food and Drug Administration for the company’s 500-milligram, 625-mg, 750-mg, 850-mg and 1000-mg versions of the drug. Ivax said final approval was subject to resolving issues involving pediatric labeling for the branded version.
Shares of Ivax rose 65 cents to $20.35 on the American Stock Exchange.
Final approvals for the generic versions have been held up by discussions between the FDA and the maker of the drug, Bristol-Myers Squibb Co., relating to additional information gathered in testing of the drug in children.
The pediatric testing already permitted Bristol-Myers an additional six months of market exclusivity over Glucophage under federal law, but the patent protection still was slated to expire months ago.
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