What's New on the FDA Drugs Site
December 30, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
December 30, 2014
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Aplenzin | bupropion hydrobromide | Tablet, Extended Release;Oral | Valeant Bermuda | Labeling Revision |
Lamictal | lamotrigine | Tablet;Oral | Glaxosmithkline Llc | Labeling Revision |
Lamictal CD | lamotrigine | Tablet, Chewable;Oral | Glaxosmithkline Llc | Labeling Revision |
Lamictal ODT | lamotrigine | Tablet, Orally Disintegrating;Oral | Glaxosmithkline Llc | Labeling Revision |
Lamictal XR | lamotrigine | Tablet, Extended Release;Oral | Glaxosmithkline Llc | Labeling Revision |
Natroba | spinosad | Suspension;Topical | Parapro Llc | Efficacy Supplement with Clinical Data to Support |
Wellbutrin XL | bupropion hydrochloride | Tablet, Extended Release;Oral | Valeant Intl | Labeling Revision |
December 29, 2014
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Gadavist | gadobutrol | Solution;Intravenous | Bayer Hlthcare | Efficacy Supplement with Clinical Data to Support |
Inlyta | axitinib | Tablet;Oral | Pfizer | Labeling Revision |
Kalydeco | ivacaftor | Tablet;Oral | Vertex Pharms | Efficacy Supplement with Clinical Data to Support |
Kalydeco | ivacaftor | Tablet;Oral | Vertex Pharms | Labeling Revision |
Omeprazole and Clarithromycin and Amoxicillin | amoxicillin; clarithromycin; omeprazole | Capsule, Tablet, Capsule, Delayed Release;Oral | Gastroentero | Labeling Revision |