What's New on the FDA Drugs Site
October 18, 2013
- Current Drug Shortages Index (updated)
- FDA approves Opsumit to treat pulmonary arterial hypertension
- Bioresearch Monitoring Information System
- Clinical Investigator Inspection List (CLIIL) Search
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Clinical Investigator Training Course, November 12-14, 2013, College Park, MD. Registration extended to 11/1/2013. Meeting information and registration .
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (FDASIA/BPCA) (updated)
- National Drug Code Directory
- Orange Book
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Appendix A: Product Name Index (PDF - 108KB)
- Appendix B: Product Name Sorted by Applicant (PDF - 406KB)
- Appendix C: Uniform Terms (PDF - 20KB)
- Orange Book Data Files (compressed) (ZIP - 566KB)
- Orange Book FR Safety or Effectiveness Determinations List (PDF - 671KB)
New and Generic Drug Approvals
October 17, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acarbose | acarbose | Tablet;Oral | Virtus Pharm | Approval |
| Cimzia | certolizumab pegol | Injectable; Injection | Ucb Inc | Efficacy Supplement with Clinical Data to Support |
| Gadavist | gadobutrol | Solution;Intravenous | Bayer Hlthcare | Labeling Revision |
| Genotropin | somatropin recombinant | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Genotropin Preservative Free | somatropin recombinant | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Janumet Xr | metformin hydrochloride; sitagliptin phosphate | Tablet, Extended Release;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Januvia | sitagliptin phosphate | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Kazano | alogliptin benzoate; metformin hydrochloride | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Lamotrigine | lamotrigine | Tablet, Extended Release;Oral | Actavis Elizabeth | Approval |
| Lanoxin | digoxin | Tablet;Oral | Covis Pharma | Labeling Revision |
| Magnevist | gadopentetate dimeglumine | Injectable;Injection | Bayer Hlthcare | Labeling Revision |
| Magnevist | gadopentetate dimeglumine | Injectable;Injection | Bayer Hlthcare | Labeling Revision |
| Prandimet | metformin hydrochloride; repaglinide | Tablet;Oral | Novo Nordisk Inc | Manufacturing Change or Addition |
| Qsymia | phentermine hydrochloride; topiramate | Capsule, Extended Release;Oral | Vivus | Manufacturing Change or Addition |
| Zemplar | paricalcitol | Capsule;Oral | Abbvie | Manufacturing Change or Addition |
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