What's New on the FDA Drugs Site
February 3, 2014
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Hetlioz (tasimelteon): first treatment for non-24 hour sleep-wake disorder in blind individuals
- National Drug Code Directory
New and Generic Drug Approvals
January 31, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acthrel | corticorelin ovine triflutate | Injectable;Injection | Ferring | Manufacturing Change or Addition |
| Atazanavir Sulfate | atazanavir sulfate | Capsule; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet, Orally Disintegrating;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet, Orally Disintegrating;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Glucophage Xr | metformin hydrochloride | Tablet, Extended Release;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Hetlioz | tasimelteon | Capsule; Oral | Vanda Pharmaceuticals Inc | Approval |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Kyprolis | carfilzomib | Powder;Intravenous | Onyx Pharms | Manufacturing Change or Addition |
| Letairis | ambrisentan | Tablet;Oral | Gilead | Labeling Revision |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Manufacturing Change or Addition |
| Propecia | finasteride | Tablet;Oral | Merck | Labeling Revision |
| Pytest | urea, c-14 | Capsule;Oral | Avent | Manufacturing Change or Addition |
| Pytest Kit | urea, c-14 | Capsule;Oral | Avent | Manufacturing Change or Addition |
| Revatio | sildenafil citrate | Tablet;Oral | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Revatio | sildenafil citrate | Tablet;Oral | Pfizer | Labeling Revision |
| Revatio | sildenafil citrate | Solution;Intravenous | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Revatio | sildenafil citrate | Solution;Intravenous | Pfizer | Labeling Revision |
| Revatio | sildenafil citrate | For Suspension;Oral | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Revatio | sildenafil citrate | For Suspension;Oral | Pfizer | Labeling Revision |
| Salonpas | menthol; methyl salicylate | Patch;Topical | Hisamitsu Pharm Co | Manufacturing Change or Addition |
| Septocaine | articaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Deproco | Manufacturing Change or Addition |
| Zetonna | ciclesonide | Aerosol, Metered;Nasal | Takeda Gmbh | Manufacturing Change or Addition |
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