New Drug Approvals Archive

Alaway (ketotifen ophthalmic) Solution

Date of Approval: December 1, 2006
Company: Alimera Sciences Inc.
Treatment for: Seasonal Allergic Conjunctivitis

Alaway (ketotifen) is an over-the-counter ophthalmic antihistamine indicated for the temporary relief of itchy eyes associated with pollen, ragweed, grass, animal hair and dander.

• Alaway Itchy Eyes - Treatment for Itchy Eyes

Alaway (ketotifen ophthalmic) FDA Approval History

Cyanokit (hydroxocobalamin) Injection

Date of Approval: December 15, 2006
Company: EMD Pharmaceuticals and Dey, LP
Treatment for: Cyanide Poisoning

Cyanokit contains hydroxocobalamin, an antidote indicated for the treatment of known or suspected cyanide poisoning.

• Cyanokit EMD Pharmaceuticals and Dey, LP - Treatment for Cyanide Poisoning

Cyanokit (hydroxocobalamin) FDA Approval History

Elestrin (estradiol) Gel - formerly Bio-E-Gel

Date of Approval: December 15, 2006
Company: BioSante Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

Elestrin is a fast-drying transdermal gel formulation of bio-identical estradiol indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.

• Elestrin BioSante Pharmaceuticals, Inc. - Treatment for Menopausal Vasomotor Symptoms

Elestrin (estradiol) FDA Approval History

Invega (paliperidone)

Date of Approval: December 19, 2006
Company: Janssen, L.P.
Treatment for: Schizophrenia

Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.

• Invega Approved By FDA as New Treatment for Schizophrenia

Invega (paliperidone) FDA Approval History

Radiesse (dermal filler) Dermal Filler

Date of Approval: December 22, 2006
Company: BioForm Medical, Inc
Treatment for: Wrinkle Correction

Radiesse is a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds.

• Radiesse BioForm Medical, Inc - Treatment for Moderate to Severe Facial Wrinkles

Radiesse (dermal filler) FDA Approval History

Invega (paliperidone)

Date of Approval: December 19, 2006
Company: Janssen, L.P.
Treatment for: Schizophrenia

Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.

• FDA Approves Invega for Long-Term Maintenance Treatment of Schizophrenia

Invega (paliperidone) FDA Approval History

Invega (paliperidone)

New Dosage Form Approved: July 31, 2009

• FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia

Invega (paliperidone) FDA Approval History

Invega (paliperidone)

New Indication Approved: July 31, 2009

• Invega Approved as the First and Only Treatment for Schizoaffective Disorder

Invega (paliperidone) FDA Approval History

Invega (paliperidone)

Patient Population Altered: April 6, 2011

• Invega Approved as Treatment for Schizophrenia in Adolescents

Invega (paliperidone) FDA Approval History