What's New on the FDA Drugs Site
July 21, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Barium Sulfate for Suspension (Currently in Shortage)
- Cidofovir Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Doxorubicin (Adriamycin) Lyophilized Powder (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- MedWatch Safety Alert: Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
July 18, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atropine Sulfate | atropine sulfate | Solution;Ophthalmic | Akorn Inc | Approval |
| Bravelle | urofollitropin | Injectable;Intramuscular, Subcutaneous | Ferring | Manufacturing Change or Addition |
| Brilinta | ticagrelor | Tablet;Oral | Astrazeneca Lp | Manufacturing Change or Addition |
| Desvenlafaxine | desvenlafaxine fumarate | Tablet, Extended Release;Oral | Teva Pharms Usa | Labeling Revision |
| Desvenlafaxine | desvenlafaxine fumarate | Tablet, Extended Release;Oral | Sun Pharma Global | Labeling Revision |
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Elliotts B Solution | calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrate | Injectable;Intrathecal | Lukare Medical Llc | Manufacturing Change or Addition |
| Etomidate | etomidate | Injectable;Injection | Zydus Pharms Usa Inc | Approval |
| Fetzima | levomilnacipran hydrochloride | Capsule, Extended Release;Oral | Forest Labs Inc | Labeling Revision |
| Fluoxetine Hydrochloride | fluoxetine hydrochloride | Tablet;Oral | Edgemont Pharms Llc | Labeling Revision |
| Kinevac | sincalide | Injectable;Injection | Bracco | Manufacturing Change or Addition |
| Luvox | fluvoxamine maleate | Tablet;Oral | Ani Pharms | Labeling Revision |
| Mesna | mesna | Injectable;Injection | Agila Speclts | Approval |
| Oxytrol | oxybutynin | Film, Extended Release;Transdermal | Watson Labs (Utah) | Manufacturing Change or Addition |
| Paxil | paroxetine hydrochloride | Tablet;Oral | Apotex Technologies | Labeling Revision |
| Paxil | paroxetine hydrochloride | Suspension;Oral | Apotex Technologies | Labeling Revision |
| Paxil Cr | paroxetine hydrochloride | Tablet, Extended Release;Oral | Apotex Technologies | Labeling Revision |
| Pexeva | paroxetine mesylate | Tablet;Oral | Noven Therap | Labeling Revision |
| Prozac | fluoxetine hydrochloride | Capsule;Oral | Eli Lilly and Co | Labeling Revision |
| Prozac Weekly | fluoxetine hydrochloride | Capsule, Delayed Rel Pellets;Oral | Lilly | Labeling Revision |
| Remeron | mirtazapine | Tablet;Oral | Organon Usa Inc | Labeling Revision |
| Remeron Soltab | mirtazapine | Tablet, Orally Disintegrating;Oral | Organon Usa Inc | Labeling Revision |
| Sarafem | fluoxetine hydrochloride | Capsule;Oral | Eli Lilly and Co | Labeling Revision |
| Stalevo 100 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Stalevo 125 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Stalevo 150 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Stalevo 200 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Stalevo 50 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Stalevo 75 | carbidopa; entacapone; levodopa | Tablet;Oral | Orion Pharma | Labeling Revision |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule;Oral | Lilly | Labeling Revision |
| Topicort | desoximetasone | Spray;Topical | Taro | Manufacturing Change or Addition |
| Venlafaxine Hydrochloride | venlafaxine hydrochloride | Tablet, Extended Release;Oral | Osmotica Pharm | Labeling Revision |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Labeling Revision |
| 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 |  |
