What's New on the FDA Drugs Site
April 12, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF - 426KB)
- Inactive Ingredients Database Download (updated)
- Inactive Ingredients Search (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (BPCA/FDASIA)
- MedWatch Safety Alert: Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns
- National Drug Code Directory (updated)
- Orange Book (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Appendix A: Product Name Index (PDF - 129KB)
- Appendix B: Product Name Sorted by Applicant (PDF - 537KB)
- Appendix C: Uniform Terms (PDF - 46KB)
- Orange Book Current Cumulative Supplement (PDF - 731KB)
- Orange Book Data Files (compressed) (ZIP - 552KB)
- Orange Book FR Safety or Effectiveness Determinations List (PDF - 209KB)
- Presentations:
New and Generic Drug Approvals
April 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amrix | cyclobenzaprine hydrochloride | Capsule, Extended Release; Oral | Ivax Intl | Labeling Revision |
| Doryx | doxycycline hyclate | Tablet, Delayed Release; Oral | Mayne Pharma | Efficacy Supplement with Clinical Data to Support |
| Doryx | doxycycline hyclate | Tablet, Delayed Release; Oral | Mayne Pharma | Manufacturing Change or Addition |
| Exidine | chlorhexidine gluconate | Aerosol, Metered; Topical | Xttrium | Labeling Revision |
| Flexeril | cyclobenzaprine hydrochloride | Tablet; Oral | Janssen Res and Dev | Labeling Revision |
| Ovidrel | choriogonadotropin alfa | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Ovidrel | choriogonadotropin alfa | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Sitagliptin Phosphate | sitagliptin phosphate | Tablet; Oral | Sun Pharma Global | Tentative Approval |
| Topicort | desoximetasone | Spray; Topical | Taro Pharma | Approval |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Trelstar | triptorelin pamoate | Injectable; Intramuscular | Watson Labs | Manufacturing Change or Addition |
| Xeomin | incobotulinumtoxina | Injectable; Injection | Merz Pharms | Labeling Revision |
| Zenpep | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release; Oral | Aptalis Pharma Us | Labeling Revision |
| Zinecard | dexrazoxane hydrochloride | Injectable; Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
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