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Listed below are the drugs granted pediatric exclusivity which have had a report on adverse events presented to the Pediatric Advisory Committee as mandated under Section 17 of the BPCA.
| Drug | Date Exclusivity Granted |
Date Reported to Advisory Committee |
|---|---|---|
| Zoloft (sertraline) | 2-1-02 | 6-12-03 |
| Ditropan (oxybutynin) | 2-8-02 | 6-12-03 |
| Lipitor (atorvastatin) | 2-22-02 | 6-12-03 |
| Zocor (simvastatin) | 2-22-02 | 6-12-03 |
| Busulfex (busulfan) | 3-12-02 | 10-29-03 |
| Zyrtec (cetirizine) | 3-13-02 | 10-29-03 |
| Cozaar (losartan) | 3-20-02 | 10-29-03 |
| Nolvadex (tamoxifen) | 5-16-02 | 10-29-03 |
| Accupril (quinapril) | 6-7-02 | 10-29-03 |
| Serzone (nefazodone) | 6-27-02 | 10-29-03 |
| Paxil (paroxetine) | 6-27-02 | 2-3-04 |
| Pravachol (pravastatin) | 7-10-02 | 2-3-04 |
| Celexa (citalopram) | 7-12-02 | 2-3-04 |
| Navelbine (vinorelbine) | 8-15-02 | 2-3-04 |
| Hycamtin (topotecan) | 11-20-02 | 6-9-04 |
| Temodar (temozolomide) | 11-20-02 | 6-9-04 |
| Effexor (venlafaxine) | 12-2-02 | 6-9-04 |
| Vigamox (moxifloxacin) | 1-10-03 | 6-9-04 |
| Ciloxan (ciprofloxacin) | 1-10-03 | 6-9-04 |
| Monopril (fosinopril) | 1-27-03 | 6-9-04 |
| Allegra (fexofenadine) | 1-27-03 | 6-9-04 |
| Duragesic (fentanyl) | 1-29-03 | 6-9-04 |
| Pulmicort/Rhinocort (budesonide) | 11-12-02 | 9-15-04 |
| Clarinex (desloratadine) | 2-12-03 | 9-15-04 |
| Cutivate/Flonase/Flovent (fluticasone), Advair (fluticasone and salmeterol) |
2-25-03 | 9-15-04 |
| Ocuflox (ofloxacin) | 3-12-03 | 9-15-04 |
| Fludara (fludarabine) | 4-03-03 | 9-15-04 |
| Fosamax (alendronate) | 4-28-03 | 9-15-04 |