New Drug Approvals Archive - August 2012
Zaltrap (ziv-aflibercept) Injection
Date of Approval: August 3, 2012
Zaltrap (ziv-aflibercept) is an angiogenesis inhibitor for the combination treatment of patients with metastatic colorectal cancer.
Marqibo (vincristine sulfate liposomes) Injection - formerly Onco TCS
Date of Approval: August 9, 2012
Marqibo (vincristine sulfate liposome injection) is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).
New Indication Approved: August 10, 2012
Auvi-Q (epinephrine) Injection
Date of Approval: August 10, 2012
Auvi-Q (epinephrine injection) is a voice-guided epinephrine auto-injector for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.
Labeling Revision Approved: August 13, 2012
Suboxone (buprenorphine and naloxone)
New Formulation Approved: August 10, 2012
New Dosage Form Approved: August 27, 2012
Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) Tablets
Date of Approval: August 27, 2012
Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) is a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
New Indication Approved: August 28, 2012
New Dosage Form Approved: August 29, 2012
Granix (tbo-filgrastim) Injection
Date of Approval: August 29, 2012
Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Linzess (linaclotide) Capsules
Date of Approval: August 30, 2012
Linzess (linaclotide) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
Xtandi (enzalutamide) Capsules
Date of Approval: August 31, 2012
Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
New Dosage Regimen: December 19, 2014
New Dosage Form Approved: January 25, 2017