What's New on the FDA Drugs Site
September 22, 2014
- Bioequivalence Recommendations for Specific Products: Estradiol; Vaginal, Cream (Draft) (PDF - 54KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Clonidine HCL Injection (Duraclon) (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
September 20, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ceftin | cefuroxime axetil | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Ceftin | cefuroxime axetil | For Suspension;Oral | Glaxosmithkline | Labeling Revision |
September 19, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ammonia N 13 Injection | ammonia n 13 injection | Injectable;Injection | Shertech Labs Llc | Approval |
| Chantix | varenicline tartrate | Tablet;Oral | Pfizer Inc | Efficacy Supplement with Clinical Data to Support |
| Chantix | varenicline tartrate | Tablet;Oral | Pfizer Inc | Labeling Revision |
| Janumet Xr | metformin hydrochloride; sitagliptin phosphate | Tablet, Extended Release;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Lexiscan | regadenoson | Solution;Intravenous | Astellas | Labeling Revision |
| Lumigan | bimatoprost | Solution/Drops;Ophthalmic | Allergan | Manufacturing Change or Addition |
| Marcaine | bupivacaine hydrochloride | Injectable;Spinal | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride | bupivacaine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride Preservative Free | bupivacaine hydrochloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine | bupivacaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free | bupivacaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Nasacort Allergy 24 Hour | triamcinolone acetonide | Spray, Metered;Nasal | Sanofi Aventis Us | Labeling Revision |
| Otezla | apremilast | Tablet;Oral | Celgene Corp | Manufacturing Change or Addition |
| Pentostatin | pentostatin | Injectable;Injection | Mylan Institutional | Approval |
| Rizatriptan Benzoate | rizatriptan benzoate | Tablet, Orally Disintegrating;Oral | Macleods Pharms Ltd | Approval |
| Temodar | temozolomide | Capsule;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
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