What's New on the FDA Drugs Site
July 12, 2013
- Bioresearch Monitoring Information System (updated)
- Bioresearch Monitoring Information System (BMIS) Download File (updated)
- Clinical Investigator Inspection List (CLIIL) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Gilotrif (afatinib), a new treatment for a type of late-stage lung cancer
- Guidance for Industry: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 463KB)
- National Drug Code Directory
New and Generic Drug Approvals
July 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Decitabine | decitabine | Injectable; Injection | Dr Reddys Labs Ltd | Approval |
| Femara | letrozole | Tablet; Oral | Novartis Pharms | Manufacturing Change or Addition |
| Ketek | telithromycin | Tablet; Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | ethinyl estradiol; norethindrone acetate | Tablet, Chewable; Oral | Warner Chilcott Llc | Labeling Revision |
| Nucynta | tapentadol hydrochloride | Tablet; Oral | Janssen Pharms | Labeling Revision |
| Oxycodone Hydrochloride; Acetaminophen | oxycodone hydrochloride; acetaminophen | Tablet; Oral | Vintage Pharms | Approval |
| Oxycodone Hydrochloride; Acetaminophen | oxycodone hydrochloride; acetaminophen | Tablet; Oral | Vintage Pharms | Approval |
| Oxymorphone Hydrochloride | oxymorphone hydrochloride | Tablet, Extended Release; Oral | Actavis Elizabeth | Approval |
| Repaglinide | repaglinide | Tablet; Oral | Caraco | Approval |
| Suprenza | phentermine hydrochloride | Tablet, Orally Disintegrating; Oral | Citius Pharms | Labeling Revision |
| Tirosint | levothyroxine sodium | Capsule; Oral | Institut Biochimique | Manufacturing Change or Addition |
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