FDA clears generic Duragesic

by | 1st Feb 2005 | News

US generics manufacturer, Mylan Laboratories, was celebrating yesterday after winning the US Food and Drug Administration green light to market its copyat version of Johnson & Johnson’s chronic pain patch, Duragesic (fentanyl transdermal system).

US generics manufacturer, Mylan Laboratories, was celebrating yesterday after winning the US Food and Drug Administration green light to market its copyat version of Johnson & Johnson’s chronic pain patch, Duragesic (fentanyl transdermal system).

Mylan’s version of the product, which the company says it will begin shipping immediately, had a long route to market after the FDA rescinded original approval after a court ruled that Mylan’s product infringed J&J patents [[24/06/04d]]. The latter company was then awarded an additional six months of marketing exclusivity.

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