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 - formerly TMC278

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