What's New on the FDA Drugs Site
December 3, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA approves Blincyto (blinatumomab) to treat a rare form of acute lymphoblastic leukemia
- FDA Drug Shortages: New and Updated
- Radium RA-223 Dichloride (Xofigo) Injection (Currently in Shortage)
- Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 209KB)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
- Pregnancy and Lactation Labeling Final Rule
New and Generic Drug Approvals
December 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acephen | acetaminophen | Suppository;Rectal | G and W Labs | Manufacturing Change or Addition |
| Actonel | risedronate sodium | Tablet;Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Bloxiverz | neostigmine methylsulfate | Solution;Intravenous | Eclat Pharms Llc | Manufacturing Change or Addition |
| Cardene | nicardipine hydrochloride | Injectable;Injection | Chiesi Usa Inc | Manufacturing Change or Addition |
| Cardene In 0.83% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Manufacturing Change or Addition |
| Cardene In 0.86% Sodium Chloride In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Manufacturing Change or Addition |
| Cardene In 4.8% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Manufacturing Change or Addition |
| Cardene In 5.0% Dextrose In Plastic Container | nicardipine hydrochloride | Injectable;Intravenous | Chiesi Usa Inc | Manufacturing Change or Addition |
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Coumadin | warfarin sodium | Injectable;Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| Coumadin | warfarin sodium | Tablet;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Delzicol | mesalamine | Capsule, Delayed Release;Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable;Injection | Pfizer Labs | Manufacturing Change or Addition |
| Dutoprol | hydrochlorothiazide; metoprolol succinate | Tablet, Extended Release;Oral | Covis Pharma Sarl | Manufacturing Change or Addition |
| Nexavar | sorafenib tosylate | Tablet;Oral | Bayer Hlthcare | Manufacturing Change or Addition |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release;Oral | Raptor Inc | Manufacturing Change or Addition |
| Sucraid | sacrosidase | Solution;Oral | Qol Medcl | Manufacturing Change or Addition |
| Symbicort | budesonide; formoterol fumarate dihydrate | Aerosol, Metered;Inhalation | Astrazeneca | Manufacturing Change or Addition |
| Targretin | bexarotene | Capsule;Oral | Valeant Luxembourg | Manufacturing Change or Addition |
| Tobramycin | tobramycin | Solution;Inhalation, Nebulizer | Pulmoflow Inc | Approval |
| Vpriv | velaglucerase alfa | Injectable;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Powder;Iv (Infusion) | Shire Human Genetic | Manufacturing Change or Addition |
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