What's New on the FDA Drugs Site
August 14, 2014
- Amgen Issues Voluntary Recall of Aranesp (darbepoetin alfa) (500 mcg) Prefilled Syringes in Several Countries Outside of the United States Due to the Presence of Visible Particulates
- Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
- FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014
- FDA approves Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia)
- FDA Drug Shortages: New and Updated
- Cefazolin Injection (Currently in Shortage)
- Cefotetan Disodium Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Ephedrine Sulfate Injection (Currently in Shortage)
- Methazolamide (Neptazane) Tablets (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Reserpine Tablets (Currently in Shortage)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
August 13, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Belsomra | suvorexant | Tablet; Oral | Merck and Co Inc | Approval |
| Depocyt | cytarabine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Manufacturing Change or Addition |
| Diprolene | betamethasone dipropionate | Ointment, Augmented;Topical | Merck Sharp Dohme | Labeling Revision |
| Diprolene | betamethasone dipropionate | Lotion, Augmented;Topical | Merck Sharp Dohme | Labeling Revision |
| Diprolene Af | betamethasone dipropionate | Cream, Augmented;Topical | Merck Sharp Dohme | Labeling Revision |
| Etomidate | etomidate | Injectable;Injection | Emcure Pharms Ltd | Approval |
| Exparel | bupivacaine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Manufacturing Change or Addition |
| Forteo | teriparatide recombinant human | Injectable;Subcutaneous | Lilly | Manufacturing Change or Addition |
| Mekinist | trametinib dimethyl sulfoxide | Tablet;Oral | Glaxosmithkline Llc | Manufacturing Change or Addition |
| Navelbine | vinorelbine tartrate | Injectable;Injection | Pierre Fabre | Manufacturing Change or Addition |
| Neuraceq | florbetaben f-18 | Solution;Intravenous | Piramal Imaging | Manufacturing Change or Addition |
| Nilandron | nilutamide | Tablet;Oral | Covis Pharma Sarl | Manufacturing Change or Addition |
| Prometrium | progesterone | Capsule;Oral | Abbvie Inc | Manufacturing Change or Addition |
| Toviaz | fesoterodine fumarate | Tablet, Extended Release;Oral | Pfizer | Manufacturing Change or Addition |
| Zyban | bupropion hydrochloride | Tablet, Extended Release;Oral | Glaxosmithkline | Labeling Revision |
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