New Drug Approvals Archive - May 2011

Fusilev (levoleucovorin)

New Indication Approved: April 29, 2011

• FDA Approves Fusilev for Use in Patients with Colorectal Cancer
• Fusilev (levoleucovorin) FDA Approval History

Nexium (esomeprazole)

Patient Population Altered: April 29, 2011

• FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients

Tradjenta (linagliptin) Tablets

Date of Approval: May 2, 2011
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Diabetes Type 2

Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• FDA Approves Tradjenta for Type 2 Diabetes
• Tradjenta (linagliptin) FDA Approval History

Docefrez (docetaxel) for Injection

Date of Approval: May 3, 2011
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer

Docefrez (docetaxel) is a microtubule inhibitor indicated for the treatment of metastatic breast cancer, metastatic non-small cell lung cancer and hormone refractory metastatic prostate cancer.

• Sun Pharma Announces US FDA Approval for Docefrez (docetaxel) for Injection
• Docefrez (docetaxel) FDA Approval History

Afinitor (everolimus)

New Indication Approved: May 6, 2011

• Novartis Gains FDA Approval for Afinitor As First New Treatment in Nearly Three Decades for Patients With Advanced Pancreatic NET
• Afinitor (everolimus) FDA Approval History

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: May 9, 2011

• FDA Licenses Fluzone Intradermal - Sanofi Pasteur's New Influenza Vaccine Delivered by Intradermal Microinjection

Victrelis (boceprevir)

Date of Approval: May 13, 2011
Company: Merck
Treatment for: Chronic Hepatitis C

Victrelis (boceprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C.

• FDA Approves Merck's Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
• Victrelis (boceprevir) FDA Approval History

Edurant (rilpivirine) Tablets

Date of Approval: May 20, 2011
Company: Tibotec Pharmaceuticals
Treatment for: HIV Infection

Edurant (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).

• FDA Approves New HIV Treatment Edurant (rilpivirine)
• Edurant (rilpivirine) FDA Approval History

Sutent (sunitinib malate)

New Indication Approved: May 20, 2011

• FDA Approves Sutent for Rare Type of Pancreatic Cancer
• Sutent (sunitinib malate) FDA Approval History

Incivek (telaprevir) Tablets

Date of Approval: May 23, 2011
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Chronic Hepatitis C

Incivek (telaprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of chronic hepatitis C (CHC).

• FDA Approves Incivek (telaprevir) for People with Hepatitis C
• Incivek (telaprevir) FDA Approval History

Dificid (fidaxomicin)

Date of Approval: May 27, 2011
Company: Optimer Pharmaceuticals, Inc.
Treatment for: Clostridial Infection

Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridium difficile-associated diarrhea.

• FDA Approves Dificid for Clostridium difficile Infection
• Dificid (fidaxomicin) 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