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  5. Products Granted a Partial Waiver Because of the Inability to Develop a Pediatric Formulation
  1. Development Resources

Products Granted a Partial Waiver Because of the Inability to Develop a Pediatric Formulation

Product Name Number Sponsor Indication Age Group Date
Invirase (saquinavir mesylate) Capsules NDA 20628/S-034 Hoffmann-La Roche, Inc. HIV-1 infection 0 to < 4 months 11/30/2012
Invirase (saquinavir mesylate) Tablets NDA 021785/S-011 Hoffmann-LaRoche, Inc. HIV-1 infection 0 to < 4 months 11/30/2012
Qnasl (beclomethasone dipropionate) Nasal Aerosol Spray NDA 202813 Teva Perennial allergic rhinitis 0 to < 4 years 12/5/2012
Hysingla ER (hydrocodone bitartrate) Extended-Release Tablets NDA 206627 Purdue Pharma L.P. Pain severe enough to require daily, around-the- clock, long-term opioid treatment 7 to < 12 years 11/20/2014
Qudexy XR (topiramate extended-release) Capsules NDA 205122 Upsher-Smith Laboratories, Inc. Adjunctive therapy in partial onset seizures (POS) 1 to 6 months 3/30/2018
Aemcolo (rifamycin) Delayed- Release Tablets NDA 210910 Cosmo Technologies, Ltd. Travelers’ diarrhea caused by noninvasive strains of Escherichia coli 3 to 5 years 11/16/2018
Furoscix Infusor (Furosemide), 80 mg/10 mL, Drug-device combination product N209988 scPharmaceuticals Services, Inc congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure 0 to 12 yrs 10/7/2022
Total 7        
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