---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jun 6, 2014 at 4:05 AM
Subject: CDER New June 6, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jun 6, 2014 at 4:05 AM
Subject: CDER New June 6, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 5, 2014
- Public Notification: Zhen Gong Fu Contains Hidden Drug Ingredient
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Public Notification: B-Perfect Contains Hidden Drug Ingredient
New and Generic Drug Approvals
June 4, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amitriptyline Hydrochloride | amitriptyline hydrochloride | Tablet;Oral | Accord Hlthcare Inc | Approval |
| Byetta | exenatide synthetic | Injectable;Subcutaneous | Astrazeneca Ab | Manufacturing Change or Addition |
| Cefepime In Plastic Container | cefepime hydrochloride | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Cevimeline Hydrochloride | cevimeline hydrochloride | Capsule;Oral | Pack Pharms Llc | Approval |
| Elidel | pimecrolimus | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Fortesta | testosterone | Gel, Metered;Transdermal | Endo Pharms | 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 |
| 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 |
| Prandimet | metformin hydrochloride; repaglinide | Tablet;Oral | Novo Nordisk Inc | Manufacturing Change or Addition |
| Prolia | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
| Vimpat | lacosamide | Tablet;Oral | Ucb Inc | Manufacturing Change or Addition |
| Vogelxo | testosterone | Gel; Transdermal | Upsher Smith Labs | Approval |
| Xgeva | denosumab | Injectable; Subcutaneous | Amgen | Labeling Revision |
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Jeremy Tobias Matthews
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