What's New on the FDA Drugs Site
October 25, 2013
- FDA approves extended-release, single-entity hydrocodone product
- Drug Firm Annual Registration Status (updated)
- FDA approves second brain imaging drug to help evaluate patients for Alzheimer’s disease, dementia
- FDA Approves Zohydro ER and Responds to CLAAD Citizen Petition
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 24, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aminohippurate Sodium | aminohippurate sodium | Injectable;Injection | Merck | Manufacturing Change or Addition |
| Biaxin | clarithromycin | For Suspension;Oral | Abbvie | Manufacturing Change or Addition |
| Ecoza | econazole nitrate | Foam; Topical | Amderma Pharmaceuticals Llc | Approval |
| Flagyl I.V. Rtu In Plastic Container | metronidazole | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Halaven | eribulin mesylate | Solution;Intravenous | Eisai Inc | Manufacturing Change or Addition |
| Innopran Xl | propranolol hydrochloride | Capsule, Extended Release;Oral | Glaxosmithkline Llc | Manufacturing Change or Addition |
| Isentress | raltegravir potassium | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Isentress | raltegravir potassium | Tablet, Chewable;Oral | Merck Sharp Dohme | Labeling Revision |
| Namenda | memantine hydrochloride | Tablet;Oral | Forest Labs | Labeling Revision |
| Namenda | memantine hydrochloride | Solution;Oral | Forest Labs | Labeling Revision |
| Tobi | tobramycin | Solution;Inhalation | Novartis Pharms | Manufacturing Change or Addition |
| Xylocaine | lidocaine hydrochloride | Jelly;Topical | Oak Pharms | Manufacturing Change or Addition |
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