What's New on the FDA Drugs Site
April 3, 2014
- Current Drug Shortages Index (updated)
- Drugs to be Discontinued: Phenylephrine (MYDFRIN) Ophthalmic Solution
-
- Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.” The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients. Meeting Information
- Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
April 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Budesonide | budesonide | Capsule;Oral | Barr Labs Div Teva | Approval |
| Clonidine Hydrochloride | clonidine hydrochloride | Tablet, Extended Release;Oral | Anchen Pharms | Approval |
| Halog | halcinonide | Cream;Topical | Ranbaxy | Manufacturing Change or Addition |
| Intron A | interferon alfa-2b | Vial | Schering | Labeling Revision |
| Solifenacin Succinate | solifenacin succinate | Tablet; Oral | Teva Pharms Usa | Approval |
| 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 |  |
