What's New on the FDA Drugs Site
July 31, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
- Spanish Drug Safety Communication: Comunicado de la FDA sobre la seguridad de los medicamentos: FDA limita el uso de tabletas orales de Nizoral (ketoconazol) debido a lesiones potencialmente fatales al hígado y riesgo de interacción con medicamentos y problemas de las glándulas suprarrenales
New and Generic Drug Approvals
July 30, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet; Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Solution; Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Tablet, Orally Disintegrating; Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Injectable; Intramuscular | Otsuka | Labeling Revision |
| Angiomax | bivalirudin | Injectable; Intravenous | Medicines Co | Manufacturing Change or Addition |
| Bupivacaine Hydrochloride | bupivacaine hydrochloride | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Bupivacaine Hydrochloride W/Epinephrine | bupivacaine hydrochloride; epinephrine bitartrate | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Concerta | methylphenidate hydrochloride | Tablet, Extended Release; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered; Inhalation | Merck Sharp Dohme | Labeling Revision |
| Fluticasone Propionate | fluticasone propionate | Lotion; Topical | Perrigo Israel | Approval |
| Lisinopril | lisinopril | Tablet; Oral | Accord Hlthcare | Approval |
| Marcaine Hydrochloride | bupivacaine hydrochloride | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride Preservative Free | bupivacaine hydrochloride | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine | bupivacaine hydrochloride; epinephrine bitartrate | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free | bupivacaine hydrochloride; epinephrine bitartrate | Injectable; Injection | Hospira | Manufacturing Change or Addition |
| Multihance | gadobenate dimeglumine | Injectable; Intravenous | Bracco | Labeling Revision |
| Multihance Multipack | gadobenate dimeglumine | Injectable; Intravenous | Bracco | Labeling Revision |
| Pepcid Complete | calcium carbonate; famotidine; magnesium hydroxide | Tablet, Chewable; Oral | Mcneil Cons | Labeling Revision |
| Sitagliptin; Metformin Hydrochloride | sitagliptin; metformin hydrochloride | Tablet; Oral | Sandoz Inc | Tentative Approval |
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