New and Generic Drug Approvals
December 11, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Vistogard | uridine triacetate | Granule;Oral | Wellstat Therap | Approval |
December 10, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cambia | diclofenac potassium | For Solution;Oral | Depomed Inc | Manufacturing Change or Addition |
| Ciprodex | ciprofloxacin; dexamethasone | Suspension/Drops;Otic | Alcon Pharms Ltd | Labeling Revision |
| Claritin | loratadine | Syrup;Oral | Bayer Healthcare Llc | Manufacturing Change or Addition |
| Claritin Hives Relief | loratadine | Syrup;Oral | Bayer Healthcare Llc | Manufacturing Change or Addition |
| Glucagen | glucagon hydrochloride recombinant | Injectable;Injection | Novo Nordisk | Labeling Revision |
| Irbesartan | irbesartan | Tablet;Oral | Ajanta Pharma Ltd | Approval |
| Otiprio | ciprofloxacin | Suspension/Drops;Otic | Otonomy Inc. | Approval |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Solution;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Spiriva | tiotropium bromide | Powder;Inhalation | Boehringer Ingelheim | Labeling Revision |
December 9, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amikacin Sulfate | amikacin sulfate | Injectable;Injection | Fresenius Kabi Usa | Approval |
| Amikacin Sulfate | amikacin sulfate | Injectable;Injection | Fresenius Kabi Usa | Approval |
| Azilect | rasagiline mesylate | Tablet;Oral | Teva | Manufacturing Change or Addition |
| Cefotan | cefotetan disodium | Injectable;Injection | Igi Labs Inc | Manufacturing Change or Addition |
| Claritin | loratadine | Capsule;Oral | Bayer Healthcare Llc | Labeling Revision |
| Cyclopentolate Hydrochloride | cyclopentolate hydrochloride | Solution/Drops;Ophthalmic | Akorn Inc | Approval |
| Diclofenac Sodium | diclofenac sodium | Solution;Topical | Novel Labs Inc | Approval |
| Hibiclens | chlorhexidine gluconate | Solution;Topical | Molnlycke Hlth | Manufacturing Change or Addition |
| Risedronate Sodium | risedronate sodium | Tablet;Oral | Macleods Pharms Ltd | Approval |
| Sirturo | bedaquiline fumarate | Tablet;Oral | Janssen Therap | Labeling Revision |
December 8, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Athentia Next | levonorgestrel | Tablet;Oral | Aurobindo Pharma Ltd | Approval |
| Eptifibatide | eptifibatide | Injectable;Injection | Aurobindo Pharma Ltd | Approval |
| Kanuma | sebelipase alfa | Injectable;Injection | Alexion Pharm | Approval |
| Metro I.V. In Plastic Container | metronidazole | Injectable;Injection | B Braun | Labeling Revision |
| Potassium Chloride | potassium chloride | Capsule, Extended Release;Oral | Pharmaceutics Intl | Approval |
| Tenofovir Disoproxil Fumarate | tenofovir disoproxil fumarate | Tablet;Oral | Mylan Pharms Inc | Tentative Approval |
| Vivitrol | naltrexone | For Suspension, Extended Release;Intramuscular | Alkermes | Manufacturing Change or Addition |
| Xtampza Er | oxycodone | Capsule, Extended Release;Oral | Collegium Pharms Inc | Tentative Approval |
December 7, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ampicillin and Sulbactam | ampicillin sodium; sulbactam sodium | Injectable;Injection | Antibiotics Sa | Approval |
| Bendeka | bendamustine hydrochloride | Injectable;Injection | Eagle Pharms | Approval |
| Children's Motrin | ibuprofen | Suspension;Oral | J and J Consumer Inc | Manufacturing Change or Addition |
| Irbesartan | irbesartan | Tablet;Oral | Unichem Labs Ltd | Approval |
| Irbesartan | irbesartan | Tablet;Oral | Sciegen Pharms Inc | Approval |
| Levothyroxine Sodium | levothyroxine sodium | Powder;Intravenous | Par Sterile Products | Approval |
| Magnevist | gadopentetate dimeglumine | Injectable;Injection | Bayer Hlthcare | Manufacturing Change or Addition |
| Memantine Hydrochloride | memantine hydrochloride | Solution;Oral | Bio-Pharm Inc | Approval |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution/Drops;Ophthalmic | Apotex Inc | Approval |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution/Drops;Ophthalmic | Usv North America | Approval |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution/Drops;Ophthalmic | Zach System Spa | Approval |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution/Drops;Ophthalmic | Novel Labs Inc | Approval |
| Xalkori | crizotinib | Capsule;Oral | Pf Prism Cv | Manufacturing Change or Addition |