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New Drug Approvals Archive - December 2006

December 2006

Alaway (ketotifen ophthalmic) Ophthalmic Solution

Date of Approval: December 1, 2006
Company: Bausch Health Companies Inc.
Treatment for: Eye Redness/Itching

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.

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.

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.

Invega (paliperidone)

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

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 treatment of schizophrenia and schizoaffective disorder.

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.

Invega (paliperidone)

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

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 treatment of schizophrenia and schizoaffective disorder.

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