New Drug Approvals Archive - August 2012

Zaltrap (ziv-aflibercept) Injection

Date of Approval: August 3, 2012
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer

Zaltrap (ziv-aflibercept) is an angiogenesis inhibitor for the combination treatment of patients with metastatic colorectal cancer.

• FDA Approves Zaltrap for Metastatic Colorectal Cancer

Zaltrap (ziv-aflibercept) FDA Approval History

Marqibo (vincristine sulfate liposomes) Injection - formerly Onco TCS

Date of Approval: August 9, 2012
Company: Talon Therapeutics Inc.
Treatment for: Acute Lymphoblastic Leukemia

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).

• FDA Approves Marqibo for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia

Marqibo (vincristine sulfate liposomes) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: August 10, 2012
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Lucentis (ranibizumab) for Treatment of Diabetic Macular Edema (DME)

Lucentis (ranibizumab) FDA Approval History

Auvi-Q (epinephrine) Injection

Date of Approval: August 10, 2012
Company: Sanofi
Treatment for: Anaphylaxis, Allergic Reaction

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.

• Sanofi Announces FDA Approval for Auvi-Q, First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies

Auvi-Q (epinephrine) FDA Approval History

Tradjenta (linagliptin)

Labeling Revision Approved: August 13, 2012

• FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes

Tradjenta (linagliptin) FDA Approval History

Suboxone (buprenorphine and naloxone)

New Formulation Approved: August 10, 2012

• Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence

Exalgo (hydromorphone)

New Dosage Form Approved: August 27, 2012
Treatment for: Pain in Opioid Tolerant Patients

• FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain

Exalgo (hydromorphone) FDA Approval History

Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) Tablets

Date of Approval: August 27, 2012
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) is a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

• FDA Approves New Combination Pill Stribild for HIV Treatment

Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) FDA Approval History

Nucynta (tapentadol)

New Indication Approved: August 28, 2012

• FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Nucynta (tapentadol) FDA Approval History

Afinitor (everolimus)

New Dosage Form Approved: August 29, 2012

• FDA Approves Afinitor Disperz - First Drug Formulated for Children with Rare Brain Tumor

Afinitor (everolimus) FDA Approval History

Granix (tbo-filgrastim) Injection

Date of Approval: August 29, 2012
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Neutropenia Associated with Chemotherapy

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.

• FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients

Granix (tbo-filgrastim) FDA Approval History

Linzess (linaclotide) Capsules

Date of Approval: August 30, 2012
Company: Allergan, Inc.
Treatment for: Irritable Bowel Syndrome, Constipation -- Chronic

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).

• FDA Approves Linzess to Treat Certain Cases of Irritable Bowel Syndrome and Constipation

Linzess (linaclotide) FDA Approval History

Xtandi (enzalutamide) Capsules

Date of Approval: August 31, 2012
Company: Medivation Inc. and Astellas Pharma Inc.
Treatment for: Prostate Cancer

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

• FDA Approves Xtandi for Late-Stage Castration-Resistant Prostate Cancer

Xtandi (enzalutamide) FDA Approval History

Granix (tbo-filgrastim)

New Dosage Regimen: December 19, 2014

• FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration

Granix (tbo-filgrastim) FDA Approval History

Linzess (linaclotide)

New Dosage Form Approved: January 25, 2017

• U.S. FDA Approves 72 mcg Dose of Linzess (linaclotide) for Adults with Chronic Idiopathic Constipation

Linzess (linaclotide) FDA Approval History