What's New on the FDA Drugs Site
August 25, 2016
- Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation Guidance for Industry (PDF- 423KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
August 24, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium | amoxicillin; clavulanate potassium | Tablet;Oral | Hikma Pharms | Approval |
| Calan | verapamil hydrochloride | Tablet;Oral | Gd Searle Llc | Labeling Revision |
| Calan | verapamil hydrochloride | Injectable;Injection | Gd Searle Llc | Labeling Revision |
| Calan Sr | verapamil hydrochloride | Tablet, Extended Release;Oral | Pfizer | Labeling Revision |
| Codeine Sulfate | codeine sulfate | Solution;Oral | Roxane | Manufacturing Change or Addition |
| Covera-Hs | verapamil hydrochloride | Tablet, Extended Release;Oral | Gd Searle Llc | Labeling Revision |
| Ethacrynate Sodium | ethacrynate sodium | Injectable;Injection | Mylan Institutional | Approval |
| Fortamet | metformin hydrochloride | Tablet, Extended Release;Oral | Andrx Labs Llc | Manufacturing Change or Addition |
| Pacitaxel | paclitaxel | Injectable;Injection | Gland Pharma Ltd | Approval |
| Paroxetine | paroxetine | Tablet, Extended Release;Oral | Lupin Ltd | Tentative Approval |
| Rhinocort | budesonide | Spray, Metered;Nasal | Astrazeneca Pharms | Labeling Revision |
| Rhinocort Allergy | budesonide | Spray, Metered;Nasal | Astrazeneca Pharms | Labeling Revision |
| Trospium Chloride | trospium chloride | Tablet;Oral | Invagen Pharms | Approval |
| Xarelto | rivaroxaban | Tablet; Oral | Janssen Pharms | Manufacturing Change or Addition |
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Friday, August 26, 2016
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