---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 21, 2014 at 7:02 AM
Subject: CDER New July 21, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 21, 2014 at 7:02 AM
Subject: CDER New July 21, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 18, 2014
- Approved Drug Product List - Orange Book: FR Notice Determination of Safety or Effectiveness List (PDF - 387KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Methylphenidate Hydrochloride Tablets (Currently in Shortage)
- National Drug Code Directory
- Orange Book (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Appendix A: Product Name Index (PDF - 128KB)
- Appendix B: Product Name Sorted by Applicant (PDF - 478KB)
- Appendix C: Uniform Terms (PDF - 55KB)
- Orange Book Current Cumulative Supplement (PDF - 887KB)
- Orange Book Data Files (compressed) (ZIP - 577KB)
New and Generic Drug Approvals
July 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abacavir Sulfate; Lamivudine | abacavir sulfate; lamivudine | Tablet; Oral | Teva Pharms | Tentative Approval |
| Adagen | pegademase bovine | Injectable;Injection | Sigma Tau | Manufacturing Change or Addition |
| Brintellix | vortioxetine hydrobromide | Tablet;Oral | Takeda Pharms Usa | Labeling Revision |
| Cymbalta | duloxetine hydrochloride | Capsule, Delayed Rel Pellets;Oral | Lilly | Labeling Revision |
| Desyrel | trazodone hydrochloride | Tablet;Oral | Apothecon | Labeling Revision |
| Epi E Z Pen Jr | epinephrine | Injectable;Intramuscular | Mylan Speclt | Labeling Revision |
| Epipen | epinephrine | Injectable;Intramuscular, Subcutaneous | Mylan Speclt | Labeling Revision |
| Epipen E Z Pen | epinephrine | Injectable;Intramuscular | Mylan Speclt | Labeling Revision |
| Epipen Jr. | epinephrine | Injectable;Intramuscular, Subcutaneous | Mylan Speclt | Labeling Revision |
| Forfivo Xl | bupropion hydrochloride | Tablet, Extended Release;Oral | Edgemont Pharms Llc | Labeling Revision |
| Oleptro | trazodone hydrochloride | Tablet, Extended Release;Oral | Angelini Pharma | Labeling Revision |
| Pristiq | desvenlafaxine succinate | Tablet, Extended Release;Oral | Wyeth Pharms Inc | Labeling Revision |
| Ropivacaine Hydrochloride | ropivacaine hydrochloride | Injectable; Injection | Navinta Llc | Approval |
| Sinemet | carbidopa; levodopa | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Sinemet Cr | carbidopa; levodopa | Tablet, Extended Release;Oral | Merck Sharp Dohme | Labeling Revision |
| Surmontil | trimipramine maleate | Capsule;Oral | Odyssey Pharms | Labeling Revision |
| Tudorza Pressair | aclidinium bromide | Powder, Metered;Inhalation | Forest Labs Inc | Labeling Revision |
| Vivactil | protriptyline hydrochloride | Tablet;Oral | Teva Womens | Labeling Revision |
| Wellbutrin | bupropion hydrochloride | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Wellbutrin Sr | bupropion hydrochloride | Tablet, Extended Release;Oral | Glaxosmithkline | Labeling Revision |
| Zosyn In Plastic Container | piperacillin sodium; tazobactam sodium | Injectable;Injection | Wyeth Pharms Inc | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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