What's New on the FDA Drugs Site
March 19, 2014
- Current Drug Shortages Index (updated)
- Drugs to be Discontinued: Phenylephrine Ophthalmic Solution
- Resolved Drug Shortages: Citric Acid; Gluconolactone; Magnesium Carbonate Solution (Renacidin) Irrigation
- Resolved Drug Shortages: Desmopressin Acetate (DDAVP) Injection
- Resolved Drug Shortages: Dipyridamole Injection
- Resolved Drug Shortages: Sulfamethoxazole 80mg/Trimethoprim 160mg/ml Injection (SMX/TMP) (Bactrim)
- Resolved Drug Shortages: Tetracycline Capsules
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- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
- Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient
New and Generic Drug Approvals
March 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acanya | benzoyl peroxide; clindamycin phosphate | Gel;Topical | Dow Pharm | Manufacturing Change or Addition |
| Amturnide | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | Tablet;Oral | Novartis | Labeling Revision |
| Atovaquone | atovaquone | Suspension;Oral | Amneal Pharms | Approval |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Janumet | metformin hydrochloride; sitagliptin phosphate | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Robinul | glycopyrrolate | Injectable;Injection | Hikma Maple | Manufacturing Change or Addition |
| Tekamlo | aliskiren hemifumarate; amlodipine besylate | Tablet;Oral | Novartis | Labeling Revision |
| Tekturna | aliskiren hemifumarate | Tablet;Oral | Novartis | Labeling Revision |
| Tekturna Hct | aliskiren hemifumarate; hydrochlorothiazide | Tablet;Oral | Novartis | Labeling Revision |
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