What's New on the FDA Drugs Site
01/23/2017 12:09 PM EST
Fresno, California (January 22, 2017) – Athens Baking Company, out of an abundance of caution, is issuing a voluntary recall of Trader Joe’s Harvest Whole Wheat Bread (SKU 00132) because it contains undeclared cultured whey, which is made from milk. Only products labeled with “BEST BY: 01/08/17” through “01/27/17” are included in this recall.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
01/20/2017 05:51 PM EST
Chip’n Dipped of Huntington, NY, is expanding its recall of it’s dark chocolate bars to include, Dark Chocolate Almond, 63% Dark Chocolate, Dark Chocolate Pretzel, Hot Dark Chocolate Habanero, Dark Chocolate Marshmallow, Extra Dark Chocolate 72% & Super Smooth Dark Chocolate 86%. People who have allergies to milk run the risk of serious or life-threatening allergic reactions if they consume these products.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
King's Pastry, located in Ontario, Canada, is voluntarily recalling the following cakes because the products contained tree nut (hazelnut) allergens that were not listed on the product labels. People who have an allergy or severe sensitivity to tree nuts (hazelnut) run the risk of serious or life-threatening allergic reaction if they consume these products.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
January 19, 2017
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Nitrous Oxide, Gas (Updated - Currently in Shortage)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)
New and Generic Drug Approvals
January 18, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aspirin and Dipyridamole ANDA #206739 | Aspirin; Dipyridamole | Capsule, Extended Release; Oral | ORIG-1 | Sandoz Inc | Approved | |
| Benlysta BLA #125370 | Belimumab | Injectable; Injection | SUPPL-57 | Human Genome Sciences Inc. | LABELING | Approved |
| Clindesse NDA #050793 | Clindamycin Phosphate | Cream; Vaginal | SUPPL-22 | Perrigo Pharma Intl | MANUF (CMC) | Approved |
| Imbruvica NDA #205552 | Ibrutinib | Capsule; Oral | SUPPL-16 | Pharmacyclics Inc | EFFICACY | Approved |
| Janumet NDA #022044 | Metformin Hydrochloride; Sitagliptin Phosphate | Tablet; Oral | SUPPL-39 | Merck Sharp Dohme | LABELING | Approved |
| Janumet NDA #022044 | Metformin Hydrochloride; Sitagliptin Phosphate | Tablet; Oral | SUPPL-40 | Merck Sharp Dohme | LABELING | Approved |
| Janumet Xr NDA #202270 | Metformin Hydrochloride; Sitagliptin Phosphate | Tablet, Extended Release; Oral | SUPPL-15 | Merck Sharp Dohme | LABELING | Approved |
| Janumet Xr NDA #202270 | Metformin Hydrochloride; Sitagliptin Phosphate | Tablet, Extended Release; Oral | SUPPL-16 | Merck Sharp Dohme | LABELING | Approved |
| Januvia NDA #021995 | Sitagliptin Phosphate | Tablet; Oral | SUPPL-38 | Merck Sharp Dohme | LABELING | Approved |
| Kombiglyze Xr NDA #200678 | Metformin Hydrochloride; Saxagliptin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-19 | Astrazeneca Ab | LABELING | Approved |
| Kombiglyze Xr NDA #200678 | Metformin Hydrochloride; Saxagliptin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-20 | Astrazeneca Ab | LABELING | Approved |
| Onglyza NDA #022350 | Saxagliptin Hydrochloride | Tablet; Oral | SUPPL-19 | Astrazeneca Ab | LABELING | Approved |
| Quetiapine Fumarate ANDA #206252 | Quetiapine Fumarate | Tablet, Extended Release; Oral | ORIG-1 | Accord Hlthcare Inc | Tentative Approval |
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