New and Generic Drug Approvals
October 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ammonia N 13 | ammonia n 13 | Injectable;Injection | The Brigham and Women's Hospital Inc | Approval |
| Bystolic | nebivolol hydrochloride | Tablet;Oral | Forest Labs | Manufacturing Change or Addition |
| Celecoxib | celecoxib | Capsule;Oral | Lupin Ltd | Approval |
| Diflucan | fluconazole | Tablet;Oral | Pfizer | Labeling Revision |
| Diflucan | fluconazole | For Suspension;Oral | Pfizer | Labeling Revision |
| Docefrez | docetaxel | Injectable;Injection | Sun Pharma Global | Labeling Revision |
| Envarsus Xr | tacrolimus | Tablet, Extended Release;Oral | Veloxis Pharma Inc | Tentative Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | The Brigham and Women's Hospital Inc | Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | Hot Shots Nm Llc | Approval |
| Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Imatinib Mesylate | imatinib mesylate | Tablet;Oral | Apotex Inc | Tentative Approval |
| Lamotrigine | lamotrigine | Tablet, Orally Disintegrating;Oral | Par Pharm Inc | Tentative Approval |
| Locoid | hydrocortisone butyrate | Cream;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Ointment;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Solution;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Lotion;Topical | Precision Dermat | Labeling Revision |
| Lopressor | metoprolol tartrate | Tablet;Oral | Us Pharms Holdings I | Manufacturing Change or Addition |
| Montelukast Sodium | montelukast sodium | Tablet;Oral | Unimark Remedies Ltd | Approval |
| Montelukast Sodium | montelukast sodium | Tablet, Chewable;Oral | Unimark Remedies Ltd | Approval |
| Mycophenolic Acid | mycophenolic acid | Tablet, Delayed Release;Oral | Teva Pharms Usa | Approval |
| Nascobal | cyanocobalamin | Spray, Metered;Nasal | Par Pharm | Manufacturing Change or Addition |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | norethindrone acetate;ethinyl estradiol ferrous fumarate | Tablet;Oral | Famy Care Ltd | Approval |
| Nutrestore | glutamine | For Solution;Oral | Emmaus Medcl | Manufacturing Change or Addition |
| Omtryg | omega-3-acid ethyl esters | Capsule;Oral | Trygg | Manufacturing Change or Addition |
| Orfadin | nitisinone | Capsule;Oral | Swedish Orphan | Manufacturing Change or Addition |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule;Oral | Lilly | Manufacturing Change or Addition |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Manufacturing Change or Addition |
| Zavesca | miglustat | Capsule;Oral | Actelion Pharms Ltd | Manufacturing Change or Addition |
| Zykadia | ceritinib | Capsule;Oral | Novartis Pharms Corp | Manufacturing Change or Addition |
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