New Formulations
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Sodium Fluoride F 18 | NIH/NCI | 1/26/2011 | |
| Fentanyl sublingual tablets | Abstral | ProStrakan, Inc. | 1/07/2011 |
| Gabapentin Tablets | Gralise | Abbott Products, Inc. | 1/28/2011 |
| Hydroxyprogesterone caproate | Makena | KV Pharmaceuticals | 2/03/2011 |
| Omeprazole, Clarithromycin, Amoxicillin | DAVA Pharmaceuticals | 2/08/2011 | |
| Topotecan Inj. | Sandoz | 2/25/2011 | |
| Topotecan Inj. | Hospira | 2/02/2011 | |
| Zidovudine Tablets | Matrix Labs | 2/23/2011 | |
| Docetaxel Inj. | Hospira | 3/03/2011 | |
| Testosterone gel | AndroGel | Abbott | 4/29/2011 |
| Argantroban in NaCl Inj | Sandoz | 5/09/2011 | |
| Docetaxel | Docefrez | Sun Pharma | 5/03/2011 |
| Argantroban in Dextrose Inj | Sandoz | 5/09/2011 | |
| Nitroglycerin | RECTIV | Prostrakan Inc | 6/21/2011 |
| Argantroban in NaCl Inj | Eagle Pharma | 6/29/2011 | |
| Fentanyl Nasal Spray | Lazanda | Archimedes | 6/30/2011 |
| Ceftazidime in Dextrose | B Braun | 6/13/2011 | |
| Docetaxel Inj | Sandoz | 6/29/2011 | |
| Oxycodone Tablets | OXECTA | King Pharma | 6/17/2011 |
| Phentiramine ODT | Suprenza | Citius Pharma | 6/13/2011 |
| Morphine Sulfate Solution | Lannett | 6/23/2011 | |
| Docetaxel Inj | Accord Healthcare | 6/08/2011 | |
| Codeine Oral Solution | Roxane Labs | 6/30/2011 | |
| Heparin Sodium Inj | Pfizer | 7/21/2011 | |
| Gemcitabine | Hospira | 8/04/2011 | |
| Purified water | Pur-Wash | Niagara Pharmaceuticals | 9/01/2011 |
| Bupivacaine Liposome Inj suspension | EXPAREL | Pacira Pharma | 10/28/2011 |
| Fluoxetine Scored Tablets | Edgemont Pharma | 10/06/2011 | |
| Zolpidem Sublingual Tablets | Intermezzo | Transcept Pharma | 11/23/2011 |
| Bupropion ER Tablets | FORFIVO XL | IntelGenx | 11/10/2011 |
| Levetiracetam Inj | HQ Speciality Pharma | 11/09/2011 | |
| Oxymorphone ER | OPANA ER | Endo Pharma | 12/09/2011 |
| Oxybutynin Gel | Anturol | Antares Pharma | 12/07/2011 |
New Molecular Entity
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Gabapentin enacarbil | Horizant | Glaxo | 4/06/2011 |
New Combinations
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Sodium Nitrite/Sodium Thiosulfate Injection | Nithiodote | Hope Pharmaceuticals | 1/14/2011 |
| Famotidine, Ibuprofen | Duexis | Horizon Pharma | 4/23/2011 |
| Chlorpheniramine, Hydrocodone, Pseudoephedrine | Zutripro | Cypress Pharma | 6/08/0211 |
| Hydrocodone, Pseudoephedrine | Rezira | Cypress Pharma | 6/08/2011 |
| Ipratropium, albuterol | Combivent Respimat | Boehringer Ingelheim | 10/07/2011 |
| Ibuprofen, Phenylephrine, Chlorpheniramine Tablets | ADVIL | Pfizer | 12/21/2011 |
| Azilsartan, Chlorthalidone Tablets | Edarbyclor | Takeda | 12/20/2011 |
Drugs Already Marketed, but Without an Approved NDA
|
Established Name |
Proprietary Name |
Applicant |
Approval |
| Levothyroxine Inj | APP Pharma | 6/24/2011 | |
| Morphine Sulfate | Hospira | 11/14/2011 | |
| Hydromorphone Inj | Hospira | 12/01/2011 |