If You Can’t Beat Them, Join Them: Mylan Reconsiders “Authorized” Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
Mylan says it is prepared to participate in the "authorized" generics market despite its opposition to such deals
You may also be interested in...
Teva Could Modify Its "Authorized" Generic Policy Following Ivax Acquisition
Deal worth $7.4 bil. brings Teva a new subsidiary that participates in the authorized generic market.
Teva Could Modify Its "Authorized" Generic Policy Following Ivax Acquisition
Deal worth $7.4 bil. brings Teva a new subsidiary that participates in the authorized generic market.
FDA’s Policy On “Authorized” Generics Upheld By Appeals Court
Waxman/Hatch provisions barring FDA from approving a later-filed ANDA do not prevent the marketing of generics under an innovator’s NDA during the 180-day exclusive period, the D.C. Circuit Court of Appeals says. The court also rejects Teva’s arguments that FDA should regulate “authorized” generics through supplemental NDAs.