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New Drug Approvals Archive

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June 2006

June 1

Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets

Date of Approval: June 1, 2006
Company: BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc.
Treatment for: Asthma -- Acute

Orapred ODT is an orally disintegrating tablet formulation of prednisolone, used to treat exacerbations of asthma and other inflammatory diseases and conditions in children. Orapred ODT tablets are grape flavored and can be swallowed whole or allowed to dissolve in the mouth, with or without the assistance of water.

Orapred ODT (prednisolone sodium phosphate) FDA Approval History

June 2

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Wrinkle Correction

Juvederm gel is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

Juvederm (dermal filler) FDA Approval History

June 8

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Injection

Date of Approval: June 8, 2006
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis

Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) in girls and women 9 through 26 years of age. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and men 9 through 26 years of age.

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

June 14

Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets

Date of Approval: June 14, 2006
Company: Valeant Pharmaceuticals International
Treatment for: Parkinson's Disease

Zelapar (selegiline) is an an irreversible inhibitor of monoamine oxidase (MAO) indicated as an adjunct in the management of patients with Parkinson’s disease.

Zelapar (selegiline hydrochloride) FDA Approval History

June 22

Opana (oxymorphone) Tablets and ER Tablets

Date of Approval: June 22, 2006
Company: Endo Pharmaceuticals Inc.
Treatment for: Pain

Opana ER (extended-release) and Opana (immediate-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time, and Opana is indicated for the relief of acute pain where the use of an opioid is appropriate.

Opana (oxymorphone) FDA Approval History

June 23

Prezista (darunavir) Tablets - formerly TMC114

Date of Approval: June 23, 2006
Company: Tibotec Pharmaceuticals Ltd.
Treatment for: HIV Infection

Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

Prezista (darunavir) FDA Approval History

June 28

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Sprycel (dasatinib) FDA Approval History

June 28

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Sprycel (dasatinib) FDA Approval History

September 15

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: September 12, 2008

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

October 22

Prezista (darunavir)

Patient Population Altered: October 21, 2008

Prezista (darunavir) FDA Approval History

May 26

Sprycel (dasatinib)

Labeling Revision Approved: May 21, 2009

Sprycel (dasatinib) FDA Approval History

October 16

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: October 16, 2009

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

January 28

Prezista (darunavir)

Labeling Revision Approved: January 27, 2010

Prezista (darunavir) FDA Approval History

June 23

Lucentis (ranibizumab)

New Indication Approved: June 22, 2010

Lucentis (ranibizumab) FDA Approval History

October 28

Sprycel (dasatinib)

New Indication Approved: October 28, 2010

Sprycel (dasatinib) FDA Approval History

December 14

Prezista (darunavir)

New Dosage Regimen: December 13, 2010

Prezista (darunavir) FDA Approval History

December 22

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: December 22, 2010

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

December 12

Opana (oxymorphone)

New Formulation Approved: December 9, 2011

Opana (oxymorphone) FDA Approval History

August 10

Lucentis (ranibizumab)

New Indication Approved: August 10, 2012

Lucentis (ranibizumab) FDA Approval History

June 21

Sprycel (dasatinib)

Labeling Revision Approved: June 17, 2013

Sprycel (dasatinib) FDA Approval History

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