New Drug Approvals Archive

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December 2006

December 1

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 (ketotifen ophthalmic) FDA Approval History

December 15

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 (hydroxocobalamin) FDA Approval History

December 15

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 (estradiol) FDA Approval History

December 19

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 (paliperidone) FDA Approval History

December 22

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 (dermal filler) FDA Approval History

December 19

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 (paliperidone) FDA Approval History

August 3

Invega (paliperidone)

New Dosage Form Approved: July 31, 2009

Invega (paliperidone) FDA Approval History

August 6

Invega (paliperidone)

New Indication Approved: July 31, 2009

Invega (paliperidone) FDA Approval History

April 11

Invega (paliperidone)

Patient Population Altered: April 6, 2011

Invega (paliperidone) FDA Approval History

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