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New Drug Approvals Archive

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May 2011

May 2

Fusilev (levoleucovorin)

New Indication Approved: April 29, 2011

Fusilev (levoleucovorin) FDA Approval History

May 2

Nexium (esomeprazole)

Patient Population Altered: April 29, 2011

May 2

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.

Tradjenta (linagliptin) FDA Approval History

May 6

Afinitor (everolimus)

New Indication Approved: May 6, 2011

Afinitor (everolimus) FDA Approval History

May 10

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: May 9, 2011

May 13

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.

Victrelis (boceprevir) FDA Approval History

May 20

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).

Edurant (rilpivirine) FDA Approval History

May 20

Sutent (sunitinib malate)

New Indication Approved: May 20, 2011

Sutent (sunitinib malate) FDA Approval History

May 23

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).

Incivek (telaprevir) FDA Approval History

May 27

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.

Dificid (fidaxomicin) FDA Approval History

August 17

Tradjenta (linagliptin)

Labeling Revision Approved: August 13, 2012

Tradjenta (linagliptin) FDA Approval History

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