New Drug Approvals Archive

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March 2009

March 3
March 5

Temodar (temozolomide)

New Dosage Form Approved: February 27, 2009

March 13

Edluar (zolpidem) Sublingual Tablets - formerly Sublinox

Date of Approval: March 13, 2009
Company: Orexo and Meda AB
Treatment for: Insomnia

Edluar (formerly Sublinox) is a fast-acting sublingual tablet formulation of the widely used drug zolpidem. Edluar is approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Edluar (zolpidem) FDA Approval History

March 20

Lexapro (escitalopram oxalate)

Patient Population Altered: March 20, 2009

March 23

Symbyax (fluoxetine and olanzapine)

New Indication Approved: March 19, 2009

March 24

Tygacil (tigecycline)

New Indication Approved: March 20, 2009

Tygacil (tigecycline) FDA Approval History

March 30

Afinitor (everolimus) Tablets

Date of Approval: March 30, 2009
Company: Novartis AG
Treatment for: Pancreatic Cancer, Renal Cell Carcinoma, Brain/Intracranial Tumor, Breast Cancer

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced kidney cancer, subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis, pancreatic neuroendocrine tumors and advanced breast cancer.

Afinitor (everolimus) FDA Approval History

March 30

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed)

Date of Approval: March 30, 2009
Company: Intercell AG
Treatment for: Japanese Encephalitis Virus Prophylaxis

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis.

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) FDA Approval History

November 1

Afinitor (everolimus)

New Indication Approved: October 29, 2010

Afinitor (everolimus) FDA Approval History

May 6

Afinitor (everolimus)

New Indication Approved: May 6, 2011

Afinitor (everolimus) FDA Approval History

April 26

Afinitor (everolimus)

Labeling Revision Approved: April 26, 2012

Afinitor (everolimus) FDA Approval History

July 20

Afinitor (everolimus)

New Indication Approved: July 20, 2012

Afinitor (everolimus) FDA Approval History

August 29

Afinitor (everolimus)

New Dosage Form Approved: August 29, 2012

Afinitor (everolimus) FDA Approval History

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