What's New on the FDA Drugs Site
December 15, 2014
- Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: Updated
- Methylphenidate Hydrochloride ER Capsules/Tablets (Currently in Shortage)
- National Drug Code Directory
New and Generic Drug Approvals
December 12, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet;Oral | Otsuka | Efficacy Supplement with Clinical Data to Support |
| Abilify | aripiprazole | Solution;Oral | Otsuka | Efficacy Supplement with Clinical Data to Support |
| Abilify | aripiprazole | Tablet, Orally Disintegrating;Oral | Otsuka | Efficacy Supplement with Clinical Data to Support |
| Abilify | aripiprazole | Injectable;Intramuscular | Otsuka | Efficacy Supplement with Clinical Data to Support |
| Cyramza | ramucirumab | Injectable;Injection | Eli Lilly and Co | Labeling Revision |
| Ellence | epirubicin hydrochloride | Injectable;Injection | Pfizer Inc | Labeling Revision |
| Hetlioz | tasimelteon | Capsule;Oral | Vanda Pharms Inc | Labeling Revision |
| Lotensin | benazepril hydrochloride | Tablet;Oral | Us Pharms Holdings I | Labeling Revision |
| Lotensin Hct | benazepril hydrochloride; hydrochlorothiazide | Tablet;Oral | Us Pharms Holdings I | Labeling Revision |
| Micardis | telmisartan | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Micardis Hct | hydrochlorothiazide; telmisartan | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Pulmozyme | dornase alfa | Vial | Genentech | Efficacy Supplement with Clinical Data to Support |
| Twynsta | amlodipine besylate; telmisartan | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Tylenol | acetaminophen | Tablet, Extended Release;Oral | Mcneil Cons | Labeling Revision |
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