What's New on the FDA Drugs Site
June 4, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (PDF - 801KB)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
June 3, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Candesartan Cilexetil and Hydrochlorothiazide | candesartan cilexetil; hydrochlorothiazide | Tablet; Oral | Apotex Inc | Approval |
| Candesartan Cilexetil and Hydrochlorothiazide | candesartan cilexetil; hydrochlorothiazide | Tablet; Oral | Dr Reddys Labs Ltd | Approval |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release; Oral | Alpharma King | Approval |
| Erivedge | vismodegib | Capsule; Oral | Genentech | Manufacturing Change or Addition |
| Fiorinal | aspirin; butalbital; caffeine | Capsule; Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Fiorinal | aspirin; butalbital; caffeine | Tablet; Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Halflytely | bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | For Solution, Tablet, Delayed Release; Oral | Braintree | Manufacturing Change or Addition |
| Halflytely | bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | Tablet, Delayed Release, For Solution; Oral | Braintree | Manufacturing Change or Addition |
| Hydroxyzine Pamoate | hydroxyzine pamoate | Capsule; Oral | Emcure Pharms Usa | Approval |
| Kalydeco | ivacaftor | Tablet; Oral | Vertex Pharms | Manufacturing Change or Addition |
| Nordette-28 | ethinyl estradiol; levonorgestrel | Tablet; Oral-28 | Teva Branded Pharm | Approval |
| Oxecta | oxycodone hydrochloride | Tablet; Oral | King Pharms R and D | Labeling Revision |
| Testosterone Cypionate | testosterone cypionate | Injectable; Injection | Sun Pharm Inds Ltd | Approval |
| Tracleer | bosentan | Tablet; Oral | Actelion Pharms Ltd | Manufacturing Change or Addition |
| 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 |
| Zoledronic Acid | zoledronic acid | Injectable; Iv (Infusion) | Hikma Farmaceutica | Approval |
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