| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cubicin | daptomycin | Powder;Intravenous | Cubist | Labeling Revision |
| Cubicin | daptomycin | Powder;Iv (Infusion) | Cubist | Labeling Revision |
| Eltrombopag | eltrombopag | Tablet;Oral | Hetero Labs Ltd V | Tentative Approval |
| Habitrol | nicotine | Film, Extended Release; Transdermal | Dr Reddys Labs Inc | Labeling Revision |
| Habitrol | nicotine | Film, Extended Release;Transdermal | Dr Reddys Labs Inc | Labeling Revision |
| Xolair | omalizumab | Vial | Genentech | Efficacy Supplement with Clinical Data to Support |
July 5, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Habitrol | nicotine | Film, Extended Release; Transdermal | Dr Reddys Labs Inc | Labeling Revision |
| Habitrol | nicotine | Film, Extended Release;Transdermal | Dr Reddys Labs Inc | Labeling Revision |
| Hydrocodone Bitartrate and Acetaminophen | acetaminophen; hydrocodone bitartrate | Tablet;Oral | Par Pharm | Approval |
| Methenamine Hippurate | methenamine hippurate | Tablet;Oral | Aurobindo Pharma Ltd | Approval |
| Pravachol | pravastatin sodium | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Tobramycin Sulfate | tobramycin sulfate | Injectable;Injection | Claris | Approval |
July 1, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Evotaz | atazanavir sulfate; cobicistat | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Febuxostat | febuxostat | Tablet;Oral | Alembic Pharms Ltd | Tentative Approval |
| Kepivance | palifermin | Injectable; Injection | Biovitrum Ab | Labeling Revision |
| Syndros | dronabinol | Solution;Oral | Insys Dev Co Inc | Labeling Revision |
June 30, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ethacrynic Acid | ethacrynic acid | Tablet;Oral | Edenbridge Pharms | Approval |
| Humira | adalimumab | Syringe | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Humira | adalimumab | Vial | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Actavis Labs Fl Inc | Manufacturing Change or Addition |
| Mobic | meloxicam | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Olmesartan Medoxomil | olmesartan medoxomil | Tablet;Oral | Alkem Labs Ltd | Tentative Approval |
| Pomalyst | pomalidomide | Capsule;Oral | Celgene | Labeling Revision |
June 29, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Levothyroxine Sodium | levothyroxine sodium | Powder;Intravenous | Fera Pharms Llc | Approval |
| Naloxone Hydrochloride | naloxone hydrochloride | Injectable;Injection | Mylan Institutional | Approval |
| Neupogen | filgrastim | Syringe | Amgen | Supplement |
| Neupogen | filgrastim | Vial | Amgen | Supplement |
| Tygacil | tigecycline | Injectable;Iv (Infusion) | Pf Prism Cv | Labeling Revision |
June 28, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Epclusa | sofosbuvir; velpatasvir | Tablet;Oral | Gilead Sciences Inc | Approval |
| Imbruvica | ibrutinib | Capsule;Oral | Pharmacyclics Inc | Labeling Revision |
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