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.

Those re­ceiv­ing a CGT des­ig­na­tion may re­ceive re­view en­hance­ments and ex­pe­dit­ed re­view of their ab­bre­vi­at­ed new drug ap­pli­ca­tions (AN­DAs). Ap­pli­cants for drugs that re­ceive a CGT des­ig­na­tion are al­so el­i­gi­ble for a 180-day pe­ri­od of mar­ket­ing ex­clu­siv­i­ty if they are the first ap­proved ap­pli­cant for that CGT and meet oth­er con­di­tions.

And in a unique twist, un­der a spe­cial for­fei­ture rule for CGTs, the ap­pli­cant must com­mer­cial­ly mar­ket the CGT with­in 75 days af­ter the date of ap­proval of its AN­DA or it will for­feit its ex­clu­siv­i­ty.

Though the CGT is on­ly for gener­ics with one com­peti­tor, in an up­date to the agency’s Man­u­al of Poli­cies and Pro­ce­dures (MAPP) in June 2017 on the pri­or­i­ti­za­tion of the re­view of AN­DAs, FDA says: “Gener­ic prod­ucts for which there are few­er than three AN­DAs ap­proved for the ref­er­ence list­ed drug (RLD) and for which there are no block­ing patents or ex­clu­siv­i­ties on the RLD may re­ceive ex­pe­dit­ed re­view.”

The potas­si­um chlo­ride oral so­lu­tion prod­ucts ap­proved Wednes­day (potas­si­um chlo­ride oral so­lu­tion USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are el­i­gi­ble for 180 days of CGT ex­clu­siv­i­ty and were ap­proved in the first cy­cle of re­view, FDA said.

FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment: “The quick im­ple­men­ta­tion of this new path­way is part of our broad­er ef­fort to fos­ter gener­ic com­pe­ti­tion and help ad­dress the high cost of drugs.”

FDA in June 2017 al­so re­leased two lists of gener­ic drugs, each of which con­tain more than 100 ac­tive in­gre­di­ents, in­clud­ing one “for which FDA could im­me­di­ate­ly ac­cept an AN­DA with­out pri­or dis­cus­sion,” and the sec­ond for drugs “in­volv­ing po­ten­tial le­gal, reg­u­la­to­ry, or sci­en­tif­ic is­sues which should be ad­dressed with the Agency pri­or to sub­mis­sion of an AN­DA.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion. 

Author

Zachary Brennan

managing editor, RAPS

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They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

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Vas Narasimhan, AP Images

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