New and Generic Drug Approvals
March 27, 2015
March 27, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amturnide | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | Tablet;Oral | Novartis | Labeling Revision |
| Aptivus | tipranavir | Capsule;Oral | Boehringer Ingelheim | Labeling Revision |
| Aptivus | tipranavir | Solution;Oral | Boehringer Ingelheim | Labeling Revision |
| Cordarone | amiodarone hydrochloride | Tablet;Oral | Wyeth Pharms Inc | Labeling Revision |
| Emsam | selegiline | Film, Extended Release;Transdermal | Somerset | Labeling Revision |
| Eovist | gadoxetate disodium | Solution;Intravenous | Bayer Hlthcare | Efficacy Supplement with Clinical Data to Support |
| Invirase | saquinavir mesylate | Capsule;Oral | Hoffmann La Roche | Labeling Revision |
| Invirase | saquinavir mesylate | Tablet;Oral | Hoffman La Roche | Labeling Revision |
| Kaletra | lopinavir; ritonavir | Capsule;Oral | Abbvie | Labeling Revision |
| Kaletra | lopinavir; ritonavir | Solution;Oral | Abbvie | Labeling Revision |
| Kaletra | lopinavir; ritonavir | Tablet;Oral | Abbvie | Labeling Revision |
| Lexiva | fosamprenavir calcium | Tablet;Oral | Viiv Hlthcare | Labeling Revision |
| Lexiva | fosamprenavir calcium | Suspension;Oral | Viiv Hlthcare | Labeling Revision |
| Mirapex | pramipexole dihydrochloride | Tablet;Oral | Boehringer Ingelheim | Labeling Revision |
| Mirapex Er | pramipexole dihydrochloride | Tablet, Extended Release;Oral | Boehringer Ingelheim | Labeling Revision |
| Norvir | ritonavir | Capsule;Oral | Abbvie | Labeling Revision |
| Prezista | darunavir ethanolate | Tablet;Oral | Janssen Prods | Labeling Revision |
| Prezista | darunavir ethanolate | Suspension;Oral | Janssen Prods | Labeling Revision |
| Reyataz | atazanavir sulfate | Capsule;Oral | Bristol Myers Squibb | Labeling Revision |
| Reyataz | atazanavir sulfate | Powder;Oral | Bristol Myers Squibb | Labeling Revision |
| Saxenda | liraglutide recombinant | Solution;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Sustiva | efavirenz | Capsule;Oral | Bristol Myers Squibb | Labeling Revision |
| Sustiva | efavirenz | Tablet;Oral | Bristol Myers Squibb | Labeling Revision |
| Tekamlo | aliskiren hemifumarate; amlodipine besylate | Tablet;Oral | Novartis | Labeling Revision |
| Tekturna | aliskiren hemifumarate | Tablet;Oral | Novartis | Labeling Revision |
| Tekturna Hct | aliskiren hemifumarate; hydrochlorothiazide | Tablet;Oral | Novartis | Labeling Revision |
| Viracept | nelfinavir mesylate | Powder;Oral | Agouron | Labeling Revision |
| Viracept | nelfinavir mesylate | Tablet;Oral | Agouron | Labeling Revision |
| Viracept | nelfinavir mesylate | Tablet;Oral | Agouron | Labeling Revision |
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