New Drug Approvals Archive - May 2012

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.

• FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease

Elelyso (taliglucerase alfa) FDA Approval History

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.

• MEDA Announces Dymista Approved by the FDA

Dymista (azelastine and fluticasone) FDA Approval History

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.

• Stiefel Receives US FDA Approval of Fabior Foam, 0.1%

Fabior (tazarotene) FDA Approval History

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.

• Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules

Pertzye (pancrelipase) FDA Approval History

Levemir (insulin detemir )

Patient Population Altered: May 18, 2012

• FDA Approves Levemir for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes

Levemir (insulin detemir ) FDA Approval History