What's New on the FDA Drugs Site
August 18, 2016
- Eighth Annual Report on Delays in Approvals of Applications Related to Citzen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015 (PDF - 2.9MB)
- Drug Trials Snapshots: NUCALA
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Chloroquine Phosphate Tablets (Updated - Resolved)
- Epinephrine Injection (Updated - Currently in Shortage)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
August 17, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aricept | donepezil hydrochloride | Tablet;Oral | Eisai Inc | Manufacturing Change or Addition |
| Farxiga | dapagliflozin propanediol | Tablet;Oral | Astrazeneca Ab | Labeling Revision |
| Invokamet | canagliflozin; metformin hydrochloride | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Invokana | canagliflozin | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Kinevac | sincalide | Injectable;Injection | Bracco | Manufacturing Change or Addition |
| Viekira Pak (Copackaged) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | Tablet, Tablet;Oral | Abbvie Inc | Manufacturing Change or Addition |
| Xarelto | rivaroxaban | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Xigduo Xr | dapagliflozin propanediol; metformin hydrochloride | Tablet, Extended Release;Oral | Astrazeneca Ab | Labeling Revision |
| Zembrace Symtouch | sumatriptan succinate | Solution;Subcutaneous | Dr Reddys Labs Ltd | Manufacturing Change or Addition |
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Friday, August 19, 2016
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