What's New on the FDA Drugs Site
August 18, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Safety Oversight Board Meeting, Public Summary, July 17, 2014
- FDA Drug Shortages: New and Updated
- Famotidine Injection (Currently in Shortage)
- Haloperidol Lactate Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. Meeting information
- MedWatch Safety Alert: Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter
- National Drug Code Directory
New and Generic Drug Approvals
August 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actoplus Met | metformin hydrochloride; pioglitazone hydrochloride | Tablet;Oral | Takeda Pharms Usa | Labeling Revision |
August 15, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify Maintena Kit | aripiprazole | For Suspension, Extended Release;Intramuscular | Otsuka Pharm Co Ltd | Manufacturing Change or Addition |
| Absorica | isotretinoin | Capsule;Oral | Ranbaxy | Manufacturing Change or Addition |
| Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Iclusig | ponatinib hydrochloride | Tablet;Oral | Ariad | Manufacturing Change or Addition |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Solution;Irrigation | Hospira | Manufacturing Change or Addition |
| Metoclopramide Hydrochloride | metoclopramide hydrochloride | Tablet, Orally Disintegrating;Oral | Novel Labs Inc | Approval |
| Olanzapine | olanzapine | Tablet;Oral | Macleods Pharms Ltd | Approval |
| Piperacillin and Tazobactam | piperacillin;tazobactam | Injectable;Injection | Agila Speclts | Approval |
| Plegridy | peginterferon beta-1a | Injectable;Injection | Biogen Idec Inc | Approval |
| Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
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