2006 Approvals
New Formulations
| Established Name |
Proprietary Name |
Applicant |
Approval |
| Fenofibrate | Lipofen | Cipher Pharmaceuticals | 11-Jan-06 |
| Naproxen Sodium | Naproxen Sodium | Banner Pharmacaps | 17-Feb-06 |
| Fluorescein Injection | Fluorescite® | Alcon | 28-Mar-06 |
| Naltrexone for extended-release injectable suspension). |
Vivitrol | Alkermes | 13-Apr-06 |
| Ibuprofen Lysine | NeoProfen® | Farmacon | 13-Apr-06 |
| Brimonidine Tartrate Ophthalmic Solution | Brimonidine Tartrate | Alcon | 22-May-06 |
| Selegiline Hydrochloride Orally Disintegrating Tablets | Zelapar | VALEANT Pharma | 14-Jun-06 |
| Lidocaine and Tetracaine Cream |
Lidocaine and Tetracaine Cream | ZARS | 29-Jun-06 |
| Prednisolone Sodium Phosphate Orally Disintegrating Tablets | Orapred ODT | Sciele | 01-Jun-06 |
| Sodium Chloride Injection, USP | Sodium Chloride Injection, USP | Mallinckrodt | 27-Jul-06 |
| MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | NORMOCARB HF | Dialysis Solutions | 26-Jul-06 |
| Fentanyl Buccal Tablet | Fentora | Cephalon | 25-Sep-06 |
| Avobenzone, Ecamsule, and Octocrylene Cream | Capital Soleil 15 | L’Oreal | 02-Oct-06 |
| CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | PrimaSol Solutions | Gambro Renal Products | 25-Oct-06 |
| Desonide Gel | Desonateâ„¢ | Dow Pharma | 20-Oct-06 |
| Nitroglycerin Lingual Aerosol | NitroMistâ„¢ | NovaDel | 02-Nov-06 |
| Ondansetron Injection | Baxter Healthcare | 27-Dec-06 | |
| Ketotifen Fumarate Ophthalmic Solution |
Alaway | Alimera Sciences | 01-Dec-06 |
New Molecular Entity
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Avobenzone, Ecamsule#, and Octocrylene Cream |
Anthelios SX | L’Oreal | 21-Jul-06*** |
New Combinations
| Established Name |
Proprietary Name |
Applicant |
Approval |
| miconazole nitrate; zinc oxide; white petrolatum Ointment. | Vusion | Barrier Therapeutics | 16-Feb-06 |
| Omeprazole; Sodium Bicarbonate | Zegerid | Santarus | 27-Feb-06 |
| Magnesium Hydroxide; Omeprazole; Sodium Bicarbonate Chewable Tablets | Zegerid w/Magnesium Hydroxide | Santarus | 24-Mar-06 |
| sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP |
Osmoprep | Salix Pharma | 16-Mar-06 |
| Articaine Hydrochloride; Epinephrine Bitartrate | Septocaine | Deproco | 30-Mar-06** |
| Pioglitazone Hydrochloride; Glimepiride | Duetact | Takeda | 28-Jul-06 |
| Metoprolol Succinate extended-release; Hydrochlorothiazide) | Dutoprolâ„¢ | AstraZeneca | 28-Aug-06 |
| Avobenzone, Ecamsule, Octocrylene and Titanium Dioxide Cream. | Various trade names | L’Oreal | 05-Oct-06 |
Drugs Already Marketed, but Without an Approved NDA
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Levothyroxine Sodium Capsules | Tirosintâ„¢ | Inst Biochimique | 13-Oct-06 |
*Approval letter ambiguous — See administrative documents for confirmation of 505(b)(2)
** a 505(b)(2) of a 505(b)(2)
# the NME
*** also a new combination