U.S. FOOD & DRUG ADMINISTRATION
What's New on the FDA Drugs Site
April 17, 2017
- Medication Guides Page (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Warning Letters 2017 (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
New and Generic Drug Approvals
April 17, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Myoview NDA #020372 | Technetium Tc-99m Tetrofosmin Kit | Injectable; Injection | SUPPL-28 | Ge Healthcare | LABELING | Approved |
| Myoview 30ml NDA #020372 | Technetium Tc-99m Tetrofosmin Kit | Injectable; Injection | SUPPL-28 | Ge Healthcare | LABELING | Approved |
| Zelboraf NDA #202429 | Vemurafenib | Tablet; Oral | SUPPL-12 | Hoffmann La Roche | LABELING | Approved |
April 15, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lucentis BLA #125156 | Ranibizumab | Injectable; Injection | SUPPL-114 | Genentech | EFFICACY | Approved |
April 14, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride ANDA #078866 | Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-11 | Sun Pharma Global | LABELING | Approved |
| Bupropion Hydrochloride ANDA #078866 | Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-12 | Sun Pharma Global | LABELING | Approved |
| Coly-Mycin M NDA #050108 | Colistimethate Sodium | Injectable; Injection | SUPPL-33 | Par Sterile Products | LABELING | Approved |
| Fentanyl Citrate ANDA #077312 | Fentanyl Citrate | Troche/Lozenge; Transmucosal | SUPPL-8 | Par Pharm | LABELING | Approved |
| Nicotine Polacrilex ANDA #076568 | Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-31 | Actavis Labs Ny Inc | LABELING | Approved |
| Nicotine Polacrilex ANDA #078697 | Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Actavis Labs Ny Inc | LABELING | Approved |
| Nicotine Polacrilex ANDA #078699 | Nicotine Polacrilex | Gum, Chewing; Buccal | SUPPL-15 | Actavis Labs Ny Inc | LABELING | Approved |
| Perphenazine ANDA #206691 | Perphenazine | Tablet; Oral | ORIG-1 | Mylan Pharms Inc | Approved | |
| Vilazodone Hydrochloride ANDA #208202 | Vilazodone Hydrochloride | Tablet; Oral | ORIG-1 | Alembic Pharms Ltd | Tentative Approval |
04/17/2017 06:37 PM EDT
Beyond Meat of El Segundo, CA is voluntarily recalling certain bags of Feisty Crumbles from three production lots because they may contain low levels of undeclared peanuts. People who have an allergy or severe sensitivity to peanuts 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.
04/17/2017 06:26 PM EDT
TP Food Processing, Inc. of Westminster, CA is recalling Lemongrass Satay; and Shrimp Satay (Lot code 2016) because the acidified sauces were not properly produced making them susceptible to contamination with Clostridium botulinum. No illnesses, customer complaints, or illnesses have been reported to date.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
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