FDA ap­proves first gener­ic drug to re­ceive CGT des­ig­na­tion

The FDA on Wednes­day ap­proved sev­er­al ver­sions of Apo­tex’s potas­si­um chlo­ride oral so­lu­tion as the first gener­ic drugs to re­ceive a Com­pet­i­tive Gener­ic Ther­a­py (CGT) des­ig­na­tion.

Thanks to the FDA Reau­tho­riza­tion Act of 2017 (FDARA), the CGT des­ig­na­tion al­lows gener­ic drugs to come to mar­ket faster than they oth­er­wise would have, but on­ly in cas­es where there is one ap­proved com­peti­tor gener­ic drug in the ac­tive sec­tion of the Or­ange Book.

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