New and Generic Drug Approvals
May 6, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Efudex | fluorouracil | Cream;Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
| Efudex | fluorouracil | Solution;Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
| Intelence | etravirine | Tablet;Oral | Janssen R and D | Manufacturing Change or Addition |
| Pennsaid | diclofenac sodium | Solution;Topical | Horizon Pharma | Package Change |
| Pepcid Ac | famotidine | Tablet;Oral | Mcneil Cons | Manufacturing Change or Addition |
May 5, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bimatoprost | bimatoprost | Solution;Ophthalmic | Alcon Res Ltd | Approval |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Docefrez | docetaxel | Injectable;Injection | Sun Pharma Global | Manufacturing Change or Addition |
| Edurant | rilpivirine hydrochloride | Tablet;Oral | Janssen Prods | Labeling Revision |
| Vibramycin | doxycycline hyclate | Capsule;Oral | Pfizer | Manufacturing Change or Addition |
| Vpriv | velaglucerase alfa | Injectable;Iv (Infusion) | Shire Human Genetic | Labeling Revision |
| Vpriv | velaglucerase alfa | Powder;Iv (Infusion) | Shire Human Genetic | Labeling Revision |
| Xarelto | rivaroxaban | Tablet;Oral | Janssen Pharms | Manufacturing Change or Addition |
May 4, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alosetron Hydrochloride | alosetron hydrochloride | Tablet;Oral | Roxane | Approval |
| Boniva | ibandronate sodium | Injectable;Intravenous | Roche | Manufacturing Change or Addition |
| Curosurf | poractant alfa | Suspension;Intratracheal | Chiesi Usa Inc | Manufacturing Change or Addition |
| Drospirenone and Ethinyl Estradiol | drospirenone; ethinyl estradiol | Tablet;Oral-28 | Famy Care Ltd | Approval |
| Neuraceq | florbetaben f-18 | Solution;Intravenous | Piramal Imaging | Manufacturing Change or Addition |
| Ultra-Technekow Fm | technetium tc-99m sodium pertechnetate generator | Solution;Intravenous | Mallinckrodt | Labeling Revision |
May 1, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aldactone | spironolactone | Tablet;Oral | Gd Searle Llc | Manufacturing Change or Addition |
| Ammonia N 13 | ammonia n-13 | Injectable;Intravenous | Biomedcl Res Fdn | Approval |
| Cefuroxime and Dextrose In Duplex Container | cefuroxime sodium | Injectable;Injection | B Braun | Labeling Revision |
| Donepezil Hydrochloride | donepezil hydrochloride | Tablet;Oral | Torrent Pharms | Manufacturing Change or Addition |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Fesoterodine Fumarate | fesoterodine fumarate | Tablet, Extended Release;Oral | Sandoz Inc | Tentative Approval |
| Fludeoxyglucose F 18 | fludeoxyglucose f-18 | Injectable;Intravenous | Biomedcl Res Fdn | Approval |
| Fludeoxyglucose F 18 | fludeoxyglucose f-18 | Injectable;Intravenous | Biomedcl Res Fdn | Approval |
| Gilenya | fingolimod | Capsule;Oral | Novartis | Labeling Revision |
| Ortho Cyclen-21 | ethinyl estradiol; norgestimate | Tablet;Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho Cyclen-28 | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen | ethinyl estradiol; norgestimate | Tablet;Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen | ethinyl estradiol; norgestimate | Tablet;Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen 21 | ethinyl estradiol; norgestimate | Tablet; Oral-21 | Ortho Mcneil Pharm | Labeling Revision |
| Ortho Tri-Cyclen 28 | ethinyl estradiol; norgestimate | Tablet; Oral-28 | Ortho Mcneil Pharm | Labeling Revision |
| Testosterone | testosterone | Gel, Metered;Transdermal | Perrigo Israel | Manufacturing Change or Addition |
| Testosterone | testosterone | Gel;Transdermal | Perrigo Israel | Manufacturing Change or Addition |
April 30, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Androderm | testosterone | Film, Extended Release;Transdermal | Actavis Labs Ut Inc | Manufacturing Change or Addition |
| Belsomra | suvorexant | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Breo Ellipta | fluticasone furoate; vilanterol trifenatate | Powder;Inhalation | Glaxo Grp Ltd | Efficacy Supplement with Clinical Data to Support |
| Calcipotriene | calcipotriene | Cream;Topical | Glenmark Generics | Tentative Approval |
| Dilantin-125 | phenytoin | Suspension;Oral | Parke Davis | Manufacturing Change or Addition |
| Dilantin-30 | phenytoin | Suspension;Oral | Parke Davis | Manufacturing Change or Addition |
| Fesoterodine Fumarate | fesoterodine fumarate | Tablet, For Suspension;Oral | Amneal Pharms | Tentative Approval |
| Ionsys | fentanyl hydrochloride | System;Iontophoresis, Transdermal | Incline Therap | Efficacy Supplement with Clinical Data to Support |
| Kimidess | desogestrel; ethinyl estradiol | Tablet;Oral-28 | Vintage Pharms | Approval |
| Lacosamide | lacosamide | Tablet;Oral | Actavis Labs Fl Inc | Tentative Approval |
| Lacosamide | lacosamide | Tablet;Oral | Amneal Pharms | Tentative Approval |
| Lacosamide | lacosamide | Tablet;Oral | Alembic Pharms Ltd | Tentative Approval |
| Lamotrigine | lamotrigine | Tablet, Orally Disintegrating;Oral | Par Pharm Inc | Tentative Approval |
| Meropenem For Injection Usp and Sodium Chloride Injection | meropenem; sodium chloride | Injectable;Injection | B Braun | Approval |
| Opsumit | macitentan | Tablet;Oral | Actelion Pharms Ltd | Labeling Revision |
| Oxaliplatin | oxaliplatin | Injectable; Iv (Infusion) | Pharmaforce | Tentative Approval |
| Phoslyra | calcium acetate | Solution;Oral | Fresenius Medcl | Labeling Revision |
| Relistor | methylnaltrexone bromide | Injectable;Subcutaneous | Salix Pharms | Manufacturing Change or Addition |
| Relistor | methylnaltrexone bromide | Solution;Subcutaneous | Salix Pharms | Manufacturing Change or Addition |
| Silvadene | silver sulfadiazine | Cream;Topical | King Pharms | Manufacturing Change or Addition |
| Tuzistra Xr | codeine polistirex; chlorpheniramine polistirex | For Suspension, Extended Release;Oral | Tris Pharma Inc | Approval |