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New Drug Approvals Archive - May 2012

May 2012

May 1

Elelyso (taliglucerase alfa) - formerly Uplyso

Date of Approval: May 1, 2012
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease

Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.

Elelyso (taliglucerase alfa) FDA Approval History

May 1

Dymista (azelastine and fluticasone) Nasal Spray

Date of Approval: May 1, 2012
Company: Meda Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis

Dymista (azelastine and fluticasone) nasal spray is an H1-receptor antagonist and corticosteroid combination indicated for the relief of symptoms of seasonal allergic rhinitis.

Dymista (azelastine and fluticasone) FDA Approval History

May 11

Fabior (tazarotene) Foam

Date of Approval: May 11, 2012
Company: Stiefel Laboratories, Inc.
Treatment for: Acne

Fabior (tazarotene) Foam is a retinoid indicated for the topical treatment of acne vulgaris.

Fabior (tazarotene) FDA Approval History

May 17

Pertzye (pancrelipase) Delayed Release Capsules

Date of Approval: May 17, 2012
Company: Digestive Care, Inc.
Treatment for: Pancreatic Exocrine Dysfunction

Pertzye (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Pertzye (pancrelipase) FDA Approval History

May 22

Levemir (insulin detemir )

Patient Population Altered: May 18, 2012

Levemir (insulin detemir ) FDA Approval History

New Drug Approvals Archive