What's New on the FDA Drugs Site
February 19, 2013
- Current Drug Shortages Index (updated)
- Drugs to be Discontinued: Flurazepam Hydrochloride Capsules, USP C-IV 15mg
- Drugs to be Discontinued: Flurazepam Hydrochloride Capsules, USP C-IV 30mg
- Drugs to be Discontinued: Hydrochlorothiazide Tablets, USP 50mg
- Drugs to be Discontinued: Hydroxychloroquine Sulfate Tablets, USP 200mg
- Drugs to be Discontinued: Lithium Carbonate Capsules USP, 300mg
- Drugs to be Discontinued: Lithium Carbonate Capsules USP, 300mg
- Drugs to be Discontinued: Lithium Carbonate Capsules USP, 300mg
- Drugs to be Discontinued: Naproxen Sodium Tablets USP, 550mg
- Drugs to be Discontinued: Trihexyphenidyl Hydrochloride Tablets, USP 2mg
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medication Guides (updated)
- MedWatch Safety Alert: Vistide (Cidofovir Injection) by Gilead: Recall - Presence of Particulate Matter
- National Drug Code Directory (updated)
New and Generic Drug Approvals
February 16, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Chorionic Gonadotropin | gonadotropin, chorionic | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Heparin Sodium | heparin sodium | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Levothyroxine Sodium | levothyroxine sodium | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Levothyroxine Sodium | levothyroxine sodium | Powder; Intravenous | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Naropin | ropivacaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Nebupent | pentamidine isethionate | For Solution; Inhalation | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Nesacaine | chloroprocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Nesacaine-Mpf | chloroprocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Pentam | pentamidine isethionate | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Tobramycin Sulfate | tobramycin sulfate | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine | lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine W/ Epinephrine | epinephrine; lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
February 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alamast | pemirolast potassium | Solution/Drops; Ophthalmic | Santen | Manufacturing Change or Addition |
| Angiomax | bivalirudin | Injectable; Intravenous | Medicines Co | Manufacturing Change or Addition |
| Apidra | insulin glulisine recombinant | Injectable; Iv (Infusion)-Sc | Sanofi Aventis Us | Manufacturing Change or Addition |
| Apidra Solostar | insulin glulisine recombinant | Injectable; Subcutaneous | Sanofi Aventis Us | Manufacturing Change or Addition |
| Aromasin | exemestane | Tablet; Oral | Pharmacia and Upjohn | Labeling Revision |
| Avagard | alcohol; chlorhexidine gluconate | Solution; Topical | 3m | Labeling Revision |
| Epiduo | adapalene; benzoyl peroxide | Gel; Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Forteo | teriparatide recombinant human | Injectable; Subcutaneous | Lilly | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| 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 |
| Levemir | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Flexpen | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Innolet | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Levemir Penfill | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Manufacturing Change or Addition |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Relenza | zanamivir | Powder; Inhalation | Glaxosmithkline | Manufacturing Change or Addition |
| Saizen | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Stribild | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Victrelis | boceprevir | Capsule; Oral | Merck Sharp Dohme | Labeling Revision |
| Welchol | colesevelam hydrochloride | For Suspension; Oral | Daiichi Sankyo | Manufacturing Change or Addition |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Zetia | ezetimibe | Tablet; Oral | Msd Intl Gmbh | Manufacturing Change or Addition |
| Zortress | everolimus | Tablet; Oral | Novartis | Efficacy Supplement with Clinical Data to Support |
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