What's New on the FDA Drugs Site
July 29, 2014
- Approved Risk Evaluation and Mitigation Strategies (REMS) page (updated)
- Bioresearch Monitoring Information System (BMIS) Search
- Bioresearch Monitoring Information System (BMIS) Download
- Clinical Investigator Inspection List (CLIIL) Search
- Clinical Investigator Inspection List (CLIIL) Download
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Selenium Injection (Currently in Shortage)
- FDA Listing of Authorized Generic Drugs (updated)
- Manual of Policies and Procedures (MAPP) 6025.6 Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics (PDF - 285KB)
- National Drug Code Directory
New and Generic Drug Approvals
July 28, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Anafranil | clomipramine hydrochloride | Capsule;Oral | Mallinckrodt Llc | Labeling Revision |
| Aromasin | exemestane | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Caduet | amlodipine besylate; atorvastatin calcium | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
| Cardura | doxazosin mesylate | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
| Cardura Xl | doxazosin mesylate | Tablet, Extended Release;Oral | Pfizer | Manufacturing Change or Addition |
| Celebrex | celecoxib | Capsule;Oral | Gd Searle | Manufacturing Change or Addition |
| Chantix | varenicline tartrate | Tablet;Oral | Pfizer Inc | Manufacturing Change or Addition |
| Detrol | tolterodine tartrate | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Detrol La | tolterodine tartrate | Capsule, Extended Release;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Diflucan | fluconazole | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
| Diflucan | fluconazole | For Suspension;Oral | Pfizer | Manufacturing Change or Addition |
| Diflucan In Dextrose 5% In Plastic Container | fluconazole | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Diflucan In Sodium Chloride 0.9% | fluconazole | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Diflucan In Sodium Chloride 0.9% In Plastic Container | fluconazole | Injectable;Injection | Pfizer | Manufacturing Change or Addition |
| Exemestane | exemestane | Tablet;Oral | Eirgen Pharma Ltd | Approval |
| Imbruvica | ibrutinib | Capsule;Oral | Pharmacyclics Inc | Efficacy Supplement with Clinical Data to Support |
| Korlym | mifepristone | Tablet;Oral | Corcept Therap | Manufacturing Change or Addition |
| Minipress | prazosin hydrochloride | Capsule;Oral | Pfizer | Manufacturing Change or Addition |
| Norvasc | amlodipine besylate | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
| Otezla | apremilast | Tablet;Oral | Celgene Corp | Manufacturing Change or Addition |
| Pamelor | nortriptyline hydrochloride | Solution;Oral | Mallinckrodt Inc | Labeling Revision |
| Pamelor | nortriptyline hydrochloride | Capsule;Oral | Mallinckrodt Llc | Labeling Revision |
| Taclonex | betamethasone dipropionate; calcipotriene hydrate | Ointment;Topical | Leo Pharma As | Labeling Revision |
| Taclonex | betamethasone dipropionate; calcipotriene hydrate | Suspension;Topical | Leo Pharma As | Labeling Revision |
| Technescan Mag3 | technetium tc-99m mertiatide kit | Injectable;Injection | Mallinckrodt | Manufacturing Change or Addition |
| Tofranil-Pm | imipramine pamoate | Capsule;Oral | Mallinckrodt Inc | Labeling Revision |
| Vascepa | icosapent ethyl | Capsule;Oral | Amarin Pharms | Manufacturing Change or Addition |
| Victrelis | boceprevir | Capsule;Oral | Merck Sharp Dohme | Labeling Revision |
| Zyvox | linezolid | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Zyvox | linezolid | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Zyvox | linezolid | For Suspension;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
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