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 |
|
Total |
6 |
|
|
|
|