New Drug Approvals Archive - March 2009

• Copaxone Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis

Temodar (temozolomide)

New Dosage Form Approved: February 27, 2009

• United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide)

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.

• Orexo's Edluar (formerly Sublinox) receives FDA approval for the treatment of insomnia

Edluar (zolpidem) FDA Approval History

Lexapro (escitalopram oxalate)

Patient Population Altered: March 20, 2009

• Forest Laboratories, Inc. Announces FDA Approval of Lexapro for the Treatment of Major Depressive Disorder in Adolescents

Symbyax (fluoxetine and olanzapine)

New Indication Approved: March 19, 2009

• FDA Approves Symbyax as First Medication for Treatment-Resistant Depression

Tygacil (tigecycline)

New Indication Approved: March 20, 2009

• FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

Tygacil (tigecycline) FDA Approval History

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 approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib

Afinitor (everolimus) FDA Approval History

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.

• Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis

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

Afinitor (everolimus)

New Indication Approved: October 29, 2010

• FDA Approves New Indication for Afinitor

Afinitor (everolimus) 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

Afinitor (everolimus)

Labeling Revision Approved: April 26, 2012

• Novartis drug Afinitor approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC

Afinitor (everolimus) FDA Approval History

Afinitor (everolimus)

New Indication Approved: July 20, 2012

• FDA Approves Afinitor for Advanced Breast Cancer

Afinitor (everolimus) FDA Approval History

Afinitor (everolimus)

New Dosage Form Approved: August 29, 2012

• FDA Approves Afinitor Disperz - First Drug Formulated for Children with Rare Brain Tumor

Afinitor (everolimus) FDA Approval History

Afinitor (everolimus)

New Indication Approved: February 26, 2016

• FDA Approves Afinitor (everolimus) for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)

Afinitor (everolimus) FDA Approval History