What's New on the FDA Drugs Site
July 29, 2016
- FDA Drug Shortages
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Sacrosidase (Sucraid) Oral Solution (Updated - Currently in Shortage)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Public Notification: Ziyinzhuangyang contains hidden drug ingredient
- Public Notification: Zi Xiu Tang Beauty Face and Figure Capsule contains hidden drug ingredients
New and Generic Drug Approvals
July 28, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aleve | naproxen sodium | Tablet;Oral | Bayer | Manufacturing Change or Addition |
| Aminosyn 10% | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 10% (Ph6) | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 5% | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 7% | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 7% (Ph6) | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 8.5% | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 8.5% (Ph6) | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Aminosyn 8.5% W/ Electrolytes | amino acids; magnesium chloride; potassium phosphate, dibasic; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Caprelsa | vandetanib | Tablet;Oral | Genzyme Corp | Labeling Revision |
| Children's Advil | ibuprofen | Suspension;Oral | Pfizer | Manufacturing Change or Addition |
| Children's Advil-Flavored | ibuprofen | Suspension;Oral | Pfizer | Manufacturing Change or Addition |
| Flovent Diskus 100 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Diskus 250 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Diskus 50 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Hfa | fluticasone propionate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Gemcitabine Hydrochloride | gemcitabine hydrochloride | Injectable;Injection | Actavis Totowa | Chemistry New Strength |
| Hylenex Recombinant | hyaluronidase recombinant human | Injectable;Injection | Halozyme Therap | Manufacturing Change or Addition |
| Mirapex | pramipexole dihydrochloride | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Mirapex Er | pramipexole dihydrochloride | Tablet, Extended Release;Oral | Boehringer Ingelheim | Labeling Revision |
| Orapred Odt | prednisolone sodium phosphate | Tablet, Orally Disintegrating;Oral | Concordia Pharms Inc | Manufacturing Change or Addition |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Triferic | ferric pyrophosphate citrate | Solution;Iv (Infusion) | Rockwell Medical Inc | Manufacturing Change or Addition |
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Monday, August 1, 2016
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