What's New on the FDA Drugs Site
February 27, 2013
- FDA Drug Safety Podcast: FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death
- Current Drug Shortages Index (updated)
- Don't take this with that! Grapefruit causes problems when taken with certain medications
- Guidance for Industry: Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (PDF - 269KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews under FDAAA (updated)
- Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Myeloid Leukemia (AML), March 4, 2013, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information
New and Generic Drug Approvals
February 26, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aceon | perindopril erbumine | Tablet; Oral | Xoma | Labeling Revision |
| Brovana | arformoterol tartrate | Solution; Inhalation | Sunovion | Manufacturing Change or Addition |
| Gonal-F | follitropin alfa/beta | Injectable; Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Mozobil | plerixafor | Solution; Subcutaneous | Genzyme | Manufacturing Change or Addition |
| Ospemifene | ospemifene | Tablet; Oral | Shionogi Inc | Approval |
| Pregnyl | gonadotropin, chorionic | Injectable; Injection | Organon Usa Inc | Manufacturing Change or Addition |
| Prinivil | lisinopril | Tablet; Oral | Merck | Labeling Revision |
| Prinzide | hydrochlorothiazide; lisinopril | Tablet; Oral | Merck | Labeling Revision |
| Risperdal Consta | risperidone | Injectable; Intramuscular | Janssen Pharms | Manufacturing Change or Addition |
| Stavzor | valproic acid | Capsule, Delayed Release; Oral | Banner Pharmacaps | Labeling Revision |
| Vumon | teniposide | Injectable; Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
