What's New on the FDA Drugs Site
March 29, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Invokana (canaglifozin) to treat type 2 diabetes
- Guidance for Industry:
- National Drug Code Directory (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
March 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amlodipine Besylate and Valsartan | amlodipine besylate; valsartan | Tablet; Oral | Par Pharm Inc | Approval |
| Amlodipine Besylate and Valsartan | amlodipine besylate; valsartan | Tablet; Oral | Par Pharm Inc | Approval |
| Amlodipine Besylate; Benazepril Hydrochloride | amlodipine besylate; benazepril hydrochloride | Capsule; Oral | Zydus Pharms Usa Inc | Tentative Approval |
| Amlodipine; Valsartan | amlodipine; valsartan | Tablet; Oral | Par Pharm Inc | Approval |
| Amlodipine; Valsartan | amlodipine; valsartan | Tablet; Oral | Par Pharm Inc | Approval |
| Carbinoxamine Maleate | carbinoxamine maleate | Suspension, Extended Release; Oral | Tris Pharma Inc | Approval |
| Cyproheptadine Hydrochloride | cyproheptadine hydrochloride | Solution; Oral | Pharm Assoc | Approval |
| Elocon | mometasone furoate | Ointment; Topical | Merck Sharp Dohme | Labeling Revision |
| Elocon | mometasone furoate | Lotion; Topical | Merck Sharp Dohme | Labeling Revision |
| Gralise | gabapentin | Tablet; Oral | Depomed Inc | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Hydralazine Hydrochloride | hydralazine hydrochloride | Injectable; Injection | Navinta Llc | Approval |
| Indomethacin | indomethacin | Capsule; Oral | Sun Pharm Inds Inc | Approval |
| Jencycla | norethindrone | Tablet; Oral | Lupin Pharms | Approval |
| Lupron Depot | leuprolide acetate | Injectable; Injection | Abbott Endocrine | Manufacturing Change or Addition |
| Merrem | meropenem | Injectable; Injection | Astrazeneca | Labeling Revision |
| Motrin Ib | ibuprofen | Tablet; Oral | Mcneil | Manufacturing Change or Addition |
| Motrin Migraine Pain | ibuprofen | Tablet; Oral | Mcneil | Manufacturing Change or Addition |
| Nithiodote | sodium nitrite; sodium thiosulfate | Solution, Solution; Intravenous, Intravenous | Hope Pharms | Manufacturing Change or Addition |
| Nuprin | ibuprofen | Tablet; Oral | Mcneil | Manufacturing Change or Addition |
| Quartette | levonorgestrel; ethinyl estradiol; ethinyl estradiol | Tablet; Oral | Teva Branded Pharm | Approval |
| Remicade | infliximab | Vial | Centocor Inc | Labeling Revision |
| Synalar | fluocinolone acetonide | Cream; Topical | Medimetriks Pharms | Manufacturing Change or Addition |
| Tylenol (Caplet) | acetaminophen | Tablet, Extended Release; Oral | Mcneil Cons | Manufacturing Change or Addition |
| Tylenol (Geltab) | acetaminophen | Tablet, Extended Release; Oral | Mcneil Cons | Manufacturing Change or Addition |
| Valcyte | valganciclovir hydrochloride | Tablet; Oral | Hoffmann La Roche | Labeling Revision |
| Valcyte | valganciclovir hydrochloride | For Solution; Oral | Hoffmann La Roche | Labeling Revision |
| Vectibix | panitumumab | Injectable; Iv (Infusion) | Amgen | Labeling Revision |
| Vivitrol | naltrexone | For Suspension, Extended Release; Intramuscular | Alkermes | Manufacturing Change or Addition |
| Xylocaine | lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Labeling Revision |
| Xylocaine 4% Preservative Free | lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine 4% Preservative Free | lidocaine hydrochloride | Solution; Topical | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Xylocaine W/ Epinephrine | epinephrine; lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Labeling Revision |
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