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New Drug Approvals Archive - March 2009

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: Renal Cell Carcinoma, Breast Cancer, Neuroendocrine Carcinoma

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

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

February 26

Afinitor (everolimus)

New Indication Approved: February 26, 2016

Afinitor (everolimus) FDA Approval History

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