Mylan Withdraws Lawsuit Against FDA
Mylan Laboratories Inc. said it had withdrawn a lawsuit against the Food and Drug Administration concerning deals involving the makers of brand-name and generic drugs, but said it might refile the suit with additional complaints.
Mylan sued the FDA in early July to protest the agency’s support for a practice by some pharmaceutical companies to authorize a generic drug company to sell a version of a particular brand-name drug.
Under current rules, the first company to develop a generic version of a drug has 180 days to sell the drug exclusively before other generic drug makers can market their versions. The practice of “authorized generics” sidesteps that provision.
In March, Mylan launched a generic version of Procter & Gamble Co.’s Macrobid, an antibiotic used to treat urinary tract infections. But Proctor & Gamble licensed a separate generic version to Watson Pharmaceuticals Inc. Mylan wants Watson to stop making its generic until after the 180-day exclusivity period, which ends next month.
Shares of Mylan fell 15 cents to $17.26 on the NYSE.
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