New Drug Approvals Archive - June 2006

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 BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc. - Treatment for Asthma and other Inflammatory Conditions in Children

Orapred ODT (prednisolone sodium phosphate) FDA Approval History

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

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

• Juvederm Allergan, Inc. - Treatment for Facial Wrinkles and Folds

Juvederm (dermal filler) FDA Approval History

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.

• FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases

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

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 Valeant Pharmaceuticals International - Treatment for Parkinson’s Disease

Zelapar (selegiline hydrochloride) FDA Approval History

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 ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain

Opana (oxymorphone) FDA Approval History

Prezista (darunavir) Tablets - formerly TMC114

Date of Approval: June 23, 2006
Company: Janssen Therapeutics
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 Tibotec Pharmaceuticals Ltd. - Treatment for Human Immunodeficiency Virus (HIV)

Prezista (darunavir) FDA Approval History

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 Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)

Sprycel (dasatinib) FDA Approval History

Lucentis (ranibizumab) Injection

Date of Approval: June 30, 2006
Company: Genentech, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

• FDA Approves Lucentis (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration

Lucentis (ranibizumab) FDA Approval History

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.

• FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Sprycel (dasatinib) FDA Approval History

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

New Indication Approved: September 12, 2008

• FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

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

Prezista (darunavir)

Patient Population Altered: October 21, 2008

• U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

Prezista (darunavir) FDA Approval History

Sprycel (dasatinib)

Labeling Revision Approved: May 21, 2009

• FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec

Sprycel (dasatinib) FDA Approval History

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

New Indication Approved: October 16, 2009

• FDA Approves Gardasil for Use in Boys and Young Men

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

Prezista (darunavir)

Labeling Revision Approved: January 27, 2010

• U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients

Prezista (darunavir) FDA Approval History

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

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

• FDA Approves Juvéderm XC Containing Lidocaine to Correct Facial Wrinkles and Folds

Juvederm (dermal filler) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: June 22, 2010
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Lucentis (ranibizumab) for the Treatment of Macular Edema Following Retinal Vein Occlusion

Lucentis (ranibizumab) FDA Approval History

Sprycel (dasatinib)

New Indication Approved: October 28, 2010

• FDA approves additional medical indication for Sprycel

Sprycel (dasatinib) FDA Approval History

Prezista (darunavir)

New Dosage Regimen: December 13, 2010

• FDA Approves Prezista/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations

Prezista (darunavir) FDA Approval History

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

New Indication Approved: December 22, 2010

• FDA: Gardasil Approved to Prevent Anal Cancer

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

Opana (oxymorphone)

New Formulation Approved: December 9, 2011

• Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant

Opana (oxymorphone) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: August 10, 2012
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Lucentis (ranibizumab) for Treatment of Diabetic Macular Edema (DME)

Lucentis (ranibizumab) FDA Approval History

Sprycel (dasatinib)

Labeling Revision Approved: June 17, 2013

• FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Sprycel (dasatinib) FDA Approval History

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

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

• FDA Approves Juvéderm Voluma XC to Correct Age-Related Volume Loss in the Cheek Area

Juvederm (dermal filler) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: February 6, 2015
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy in People with Diabetic Macular Edema

Lucentis (ranibizumab) FDA Approval History

Juvederm (dermal filler)

New Formulation Approved: October 1, 2015
Treatment for: Facial Rejuvenation

• FDA Approves Juvéderm Ultra XC for Lip Augmentation

Juvederm (dermal filler) FDA Approval History

Juvederm (dermal filler)

New Formulation Approved: June 1, 2016
Treatment for: Facial Rejuvenation

• FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids

Juvederm (dermal filler) FDA Approval History

Prezista (darunavir)

Patient Population Altered: June 17, 2016

• U.S. FDA Approves Prezista (darunavir) for Use in Pregnant Women with HIV

Prezista (darunavir) FDA Approval History

Lucentis (ranibizumab)

New Dosage Form Approved: October 13, 2016
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Genentech’s Lucentis (ranibizumab) Prefilled Syringe

Lucentis (ranibizumab) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: January 5, 2017
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization

Lucentis (ranibizumab) FDA Approval History

Juvederm (dermal filler)

New Formulation Approved: March 20, 2017
Treatment for: Facial Rejuvenation

• FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults

Juvederm (dermal filler) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: April 15, 2017
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

Lucentis (ranibizumab) FDA Approval History