What's New on the FDA Drugs Site
May 1, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA News Release: FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
- FDA Drug Safety Podcast: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 30, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenosine | adenosine | Injectable; Injection | Emcure Pharms Ltd | Tentative Approval |
| Avodart | dutasteride | Capsule; Oral | Glaxosmithkline | Labeling Revision |
| Clindamycin Palmitate Hydrochloride | clindamycin palmitate hydrochloride | For Solution; Oral | Aurobindo Pharma Ltd | Approval |
| Doxycycline Hyclate | doxycycline hyclate | Tablet, Delayed Release; Oral | Heritage Pharms Inc | Approval |
| Intelence | etravirine | Tablet; Oral | Janssen R and D | Manufacturing Change or Addition |
| Plan B One-Step | levonorgestrel | Tablet; Oral | Duramed | Efficacy Supplement with Clinical Data to Support |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release; Oral | Raptor Pharma Corp | Approval |
| Seroquel | quetiapine fumarate | Tablet; Oral | Astrazeneca | Efficacy Supplement with Clinical Data to Support |
| Seroquel | quetiapine fumarate | Tablet; Oral | Astrazeneca | Labeling Revision |
| Seroquel Xr | quetiapine fumarate | Tablet, Extended Release; Oral | Astrazeneca | Efficacy Supplement with Clinical Data to Support |
| Seroquel Xr | quetiapine fumarate | Tablet, Extended Release; Oral | Astrazeneca | Labeling Revision |
| Tamsulosin Hydrochloride | tamsulosin hydrochloride | Capsule; Oral | Aurobindo Pharma Ltd | Approval |
| Tasmar | tolcapone | Tablet; Oral | Valeant Pharms Llc | Manufacturing Change or Addition |
| Transderm Scop | scopolamine | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
| Tyvaso | treprostinil sodium | Solution; Inhalation | United Therap | Labeling Revision |
| Valsartan | valsartan | Tablet; Oral | Alembic Pharms Ltd | Tentative 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 |  |
