What's New on the FDA Drugs Site
September 24, 2013
- Public Notification: XZen 1200 Contains Hidden Drug Ingredient
- Public Notification: XZone Premium Contains Hidden Drug Ingredient
- Public Notification: Wood-E Contains Hidden Drug Ingredient
- Public Notification: Xzen Gold Contains Hidden Drug Ingredient
- Public Notification: Xzen XPress Contains Hidden Drug Ingredient
- FDA Drug Safety Podcast: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP): 5200.3 (PDF - 35KB) Responding to Industry Inquiries with respect to Abbreviated New Drug Applications in the Office of Generic Drugs
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
September 23, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Accupril | quinapril hydrochloride | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Accuretic | hydrochlorothiazide; quinapril hydrochloride | Tablet;Oral | Pfizer Pharms | Labeling Revision |
| Altace | ramipril | Capsule;Oral | King Pharms | Labeling Revision |
| Bivalirudin | bivalirudin | Injectable; Injection | Hospira Inc | Tentative Approval |
| Duragesic-100 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-12 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-25 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-50 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Duragesic-75 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Golytely | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution;Oral | Braintree | Labeling Revision |
| Hectorol | doxercalciferol | Injectable;Injection | Genzyme Corp | Manufacturing Change or Addition |
| Methylphenidate Hydrochloride | methylphenidate hydrochloride | Tablet, Extended Release; Oral | Kudco Ireland | Approval |
| Methylphenidate Hydrochloride | methylphenidate hydrochloride | Tablet, Extended Release;Oral | Kudco Ireland | Approval |
| Nulytely | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | For Solution;Oral | Braintree | Labeling Revision |
| Nulytely-Flavored | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | For Solution;Oral | Braintree | Labeling Revision |
| Suprane | desflurane | Liquid;Inhalation | Baxter Hlthcare | Labeling Revision |
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