New and Generic Drug Approvals
March 30, 2015
March 30, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aceon | perindopril erbumine | Tablet;Oral | Symplmed Pharms Llc | Labeling Revision |
| Advil Congestion Relief | ibuprofen; phenylephrine hydrochloride | Tablet;Oral | Pfizer | Labeling Revision |
| Cesamet | nabilone | Capsule;Oral | Meda Pharms | Manufacturing Change or Addition |
| Choline C-11 | choline c-11 | Injectable;Intravenous | Mcprf | Manufacturing Change or Addition |
| Depakote Er | divalproex sodium | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Edecrin | ethacrynic acid | Tablet;Oral | Aton | Manufacturing Change or Addition |
| Estrostep 21 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-21 | Warner Chilcott Llc | Manufacturing Change or Addition |
| Estrostep Fe | ethinyl estradiol; norethindrone acetate | Tablet;Oral-28 | Warner Chilcott Llc | Manufacturing Change or Addition |
| Fanapt | iloperidone | Tablet;Oral | Vanda Pharms Inc | Manufacturing Change or Addition |
| Omeprazole | omeprazole | Tablet, Delayed Release;Oral | Dexcel Pharma | Manufacturing Change or Addition |
| Pancreaze | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Qudexy Xr | topiramate | Capsule, Extended Release;Oral | Upsher Smith | Efficacy Supplement with Clinical Data to Support |
| Rapamune | sirolimus | Tablet;Oral | Pf Prism Cv | Manufacturing Change or Addition |
| Retisert | fluocinolone acetonide | Implant;Intravitreal | Bausch and Lomb | Manufacturing Change or Addition |
| Salonpas | menthol; methyl salicylate | Patch;Topical | Hisamitsu Pharm Co | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Solution;Irrigation | B Braun | Manufacturing Change or Addition |
| Solaraze | diclofenac sodium | Gel;Topical | Fougera Pharms | Manufacturing Change or Addition |
| Sterile Water In Plastic Container | sterile water for irrigation | Liquid;Irrigation | B Braun | Manufacturing Change or Addition |
| Topotecan Hydrochloride | topotecan hydrochloride | Solution;Intravenous | Teva Pharms Usa | Manufacturing Change or Addition |
| Urex | methenamine hippurate | Tablet;Oral | Cnty Line Pharms | Manufacturing Change or Addition |
| Zaroxolyn | metolazone | Tablet;Oral | Ucb Inc | Manufacturing Change or Addition |
Topotecan Hydrochloride is the water-soluble hydrochloride salt preparation of Topotecan, a potent inhibitor of topoisomerase 1, and an apoptosis inducer, producing proapoptotic and antiproliferative effects. Topotecan Hydrochloride
ReplyDelete