2005 Approvals
New Formulations
| Established Name |
Proprietary Name |
Applicant |
Approval |
| Cyanocobalamin, USP Nasal Spray | Nascobal | Nastech Pharma | 31-Jan-05 |
| paclitaxel protein-bound particles for injectable suspension | Abraxane | American BioScience | 07-Jan-05 |
| Alprazolam Orally Disintegrating Tablets | Niravamâ„¢ | Schwarz Pharma | 19-Jan-05 |
| sodium phenylacetate and sodium benzoate Injection | Ammonul | Ucyclyd | 17-Feb-05 |
| Levabuterol Tartrate | Xopenex | Sepracor | 11-Mar-05 |
| Chlorhexidine Gluconate | Chlorhexidine Gluconate Cloth | Sage Products | 25-Apr-05 |
| Fenofibrate Tablets | Triglide | Skye Pharma | 07-May-05 |
| Tramadol Hydrochloride Orally Disintegrating Tablets | Tramadol HCl ODT | Biovail | 05-May-05 |
| Metronidazole Vaginal Gel | Metronidazole Vaginal Gel | Teva | 20-May-05 |
| Chlorhexidine Gluconate and Isopropyl Alcohol | Chloroscrubâ„¢ Swab, Swabstick, Maxi Swabstick | SoluMed | 03-Jun-05 |
| Metronidazole Gel | Metrogel | Dow Pharma | 30-Jun-05 |
| Megestrol Acetate Oral Suspension | Megace ES | Par Pharma | 05-Jul-05 |
| Calcitonin Salmon Recombinant | Fortical Nasal Spray | Unigene Labs | 12-Aug-05 |
| Loperamide HCl Capsules | N/A | Banner Pharmacaps | 04-Aug-05 |
| Fludeoxyglucose F 18 Injection. | N/A | Feinstein | 19-Aug-05 |
| Tramadol HCl Extended Release Tablets | Biovail | 08-Sep-05 | |
| Loratadine Oral Suspension | N/A | Taro | 04-Oct-05 |
| Tamoxifen Citrate Oral Solution | Soltamox | Savient Pharma | 29-Oct-05 |
| Citalopram HBr Orally Disintegrating Tablets | N/A | Biovail | 20-Dec-05 |
New Molecular Entity
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Hyaluronidase Human Injection | Hylenex Recombinant | Halozyme Therapeutics | 02-Dec-05 |
New Combinations
| Established Name |
Proprietary Name |
Applicant |
Approval |
| Desloratadine; Pseudoephedrine Sulfate Extended Release Tablets | Clarinex-D 24 Hour | Schering | 03-Mar-05** |
| Alendronate Sodium; Vitamin D | Fosamax Plus D | Merck | 07-Apr-05 ** |
| Isosorbide Dinitrate; Hydralazine HCl | BiDil | NitroMed | 23-Jun-05 ** |
| Lidocaine; Terracaine Topical Patch | Synera | Zars | 23-Jun-05 |
| Risedronate Sodium; Calcium | Actonel with Calcium | P&G Pharma | 12-Aug-05 |
| Pioglitazone HCl; Metformin HCl | Actoplus Metâ„¢ | Takeda | 29-Aug-05 |
Drugs Already Marketed, but Without an Approved NDA
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Quinine Sulfate | Qualiquin | Mutual Pharma | 12-Aug-05** |
*Approval letter ambiguous — See administrative documents for confirmation of 505(b)(2)
** See administrative documents (p. 49 for Clarinex; p/ 32 for Fosamax; p. 29 for BiDil; p. 2 for Fortical; p. 6 for Quinine)