What's New on the FDA Drugs Site
July 31, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates
- FDA Drug Shortages: New and Updated
- Cidofovir Injection (Discontinuation)
- Ranitidine Hydrochloride (Zantac) Injection (Currently in Shortage)
-
New and Generic Drug Approvals
July 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Absorica | isotretinoin | Capsule;Oral | Ranbaxy | Labeling Revision |
| Amoxil | amoxicillin | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Belviq | lorcaserin hydrochloride | Tablet;Oral | Eisai Inc | Manufacturing Change or Addition |
| Canasa | mesalamine | Suppository;Rectal | Forest Labs Inc | Manufacturing Change or Addition |
| Diclegis | doxylamine succinate; pyridoxine hydrochloride | Tablet, Delayed Release;Oral | Duchesnay | Manufacturing Change or Addition |
| Excedrin (Migraine) | acetaminophen; aspirin; caffeine | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Humatrope | somatropin recombinant | Injectable;Injection | Lilly | Labeling Revision |
| Iclusig | ponatinib hydrochloride | Tablet;Oral | Ariad | Manufacturing Change or Addition |
| Jentadueto | linagliptin; metformin hydrochloride | Tablet;Oral | Boehringer Ingelheim | Efficacy Supplement with Clinical Data to Support |
| Quelicin | succinylcholine chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Quelicin Preservative Free | succinylcholine chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
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