New Drug Approvals Archive

New Drug Approvals: December 2006

December 1
Alaway (ketotifen ophthalmic) Solution

Date of Approval: December 1, 2006

Company: Alimera Sciences Inc.

Treatment for Seasonal Allergic Conjunctivitis

Alaway 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
 
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 EMD Pharmaceuticals and Dey, LP - Treatment for Cyanide Poisoning
 
December 18
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
 
December 21
Invega (paliperidone) Extended-Release Tablets

Date of Approval: December 19, 2006

Company: Janssen, L.P.

Treatment for Schizophrenia

Invega is a once-daily oral atypical antipsychotic indicated for the treatment of schizophrenia.

Invega Approved By FDA as New Treatment for Schizophrenia
 
December 27
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
 
December 28 FDA Approves Radiesse Facial Filler for Two New Aesthetic Indications
 
December 30 FDA Approves Radiesse for Treating Facial Lipoatrophy
 

New Drug Approvals Archive

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