What's New on the FDA Drugs Site
October 12, 2016
- CDER Statement: FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections (update)
- Drug Approval Packages:
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- La FDA advierte sobre el riesgo de reactivación de la hepatitis B en algunos pacientes tratados con antivirales de acción directa para la hepatitis C
- FDA Public Workshop: Cardiovascular Toxicity Assessment in Oncology Trials (updated)
- Medication Guides Page (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
October 11, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amitiza | lubiprostone | Capsule;Oral | Sucampo Pharma Llc | Labeling Revision |
| Cefazolin In Plastic Container | cefazolin sodium | Solution;Intravenous | Baxter Hlthcare | Labeling Revision |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium | drospirenone; ethinyl estradiol; levomefolate calcium | Tablet;Oral | Watson Labs Inc | Approval |
| Drospirenone;Ethinyl Estradiol;Levomefolate Calcium;Levomefolate Calcium | drospirenone;ethinyl estradiol;levomefolate calcium;levomefolate calcium | Tablet;Oral | Watson Labs | Approval |
| Elidel | pimecrolimus | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Erbitux | cetuximab | Vial; Intravenous | Imclone | Labeling Revision |
| Harvoni | ledipasvir; sofosbuvir | Tablet;Oral | Gilead Sciences Inc | Manufacturing Change or Addition |
| Neoral | cyclosporine | Capsule;Oral | Novartis | Manufacturing Change or Addition |
| Orenitram | treprostinil diolamine | Tablet, Extended Release;Oral | United Therap | Manufacturing Change or Addition |
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Thursday, October 13, 2016
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