Tuesday, February 22, 2011

Authorized generics may not be allowed during 180 day exclusivity

In Hatch Waxman act, the legislation have given the opportunity of 180 days exclusivity to generics on filing ANDA with paragraph IV certification during which FDA can not grant any other ANDA but innovators play game in term of introducing authorized generic in market during 180 days exclusivity of generic player to reduce the profit of generics and to reduce the loss of themselves. However now this game will be no more allowed due to changes in the legislation.
For full details please click here

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