New Drug Approvals Archive

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August 2012

August 3

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.

Zaltrap (ziv-aflibercept) FDA Approval History

August 9

Marqibo (vincristine sulfate liposomes) Injection

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).

Marqibo (vincristine sulfate liposomes) FDA Approval History

August 10

Lucentis (ranibizumab)

New Indication Approved: August 10, 2012

Lucentis (ranibizumab) FDA Approval History

August 10

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.

Auvi-Q (epinephrine) FDA Approval History

August 17

Tradjenta (linagliptin)

Labeling Revision Approved: August 13, 2012

Tradjenta (linagliptin) FDA Approval History

August 20

Suboxone (buprenorphine and naloxone)

New Formulation Approved: August 10, 2012

August 27

Exalgo (hydromorphone)

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

Exalgo (hydromorphone) FDA Approval History

August 27

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.

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

August 29

Nucynta (tapentadol)

New Indication Approved: August 28, 2012

Nucynta (tapentadol) FDA Approval History

August 29

Afinitor (everolimus)

New Dosage Form Approved: August 29, 2012

Afinitor (everolimus) FDA Approval History

August 29

(tbo-filgrastim) Injection

Date of Approval: August 29, 2012
Company: Sicor Biotech
Treatment for: Neutropenia Associated with Chemotherapy

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.

tbo-filgrastim FDA Approval History

August 30

Linzess (linaclotide) Capsules

Date of Approval: August 30, 2012
Company: Ironwood Pharmaceuticals, Inc. and Forest Laboratories, 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).

Linzess (linaclotide) FDA Approval History

August 31

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.

Xtandi (enzalutamide) FDA Approval History

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