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Padagis Seeks To Challenge Hikma’s Kloxxado

Naloxone 8mg Nasal Spray Is Among Firm’s Latest First-To-File Targets

 
• By Dave Wallace

Padagis has set out two first-to-file ANDA submissions in the US, challenging Hikma’s Kloxxado as well as Evofem’s Phexxi. The former Perrigo Rx business has also just launched two limited-competition generics.

Padagis has filed an ANDA for a naloxone 8mg nasal spray

Hikma’s Kloxxado (naloxone) 8mg nasal spray is among two products being targeted by Padagis as part of the former Perrigo Rx unit’s latest pair of first-to-file abbreviated new drug application submissions in the US.

Kloxxado, an 8mg alternative to the 4mg Narcan naloxone brand, was launched by Hikma nearly two years ago following US Food and Drug Administration approval via the 505(b)(2) hybrid pathway

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