New Drug Approvals Archive - January 2007

Olux-E (clobetasol propionate) Foam

Date of Approval: January 12, 2007
Company: Stiefel Laboratories, Inc.
Treatment for: Psoriasis, Eczema

Olux-E (clobetasol propionate) is a topical steroid formulated in VersaFoam emulsion foam drug delivery vehicle indicated for the treatment of psoriasis and eczema in patients 12 years of age or older.

• Olux-E Stiefel Laboratories, Inc. - Treatment for Psoriasis and Eczema
• Olux-E (clobetasol propionate) FDA Approval History

Lialda (mesalamine) Delayed Release Tablets

Date of Approval: January 16, 2007
Company: Shire plc
Treatment for: Ulcerative Colitis

Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

• Lialda Shire plc - Treatment for Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History

Lialda (mesalamine) Delayed Release Tablets

Date of Approval: January 16, 2007
Company: Shire plc
Treatment for: Ulcerative Colitis

Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.

• FDA Approves Lialda (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History

Vidaza (azacitidine)

New Dosage Form Approved: January 26, 2007

• Pharmion Corporation Announces FDA Approval of Vidaza NDASupplement for IV Administration
• Vidaza (azacitidine) FDA Approval History

Flector (diclofenac epolamine) Topical Patch

Date of Approval: January 31, 2007
Company: Institut Biochimique SA
Treatment for: Pain

Flector is a transdermal patch formulation of the nonsteroidal anti-inflammatory drug diclofenac, indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

• Flector Approved - Institut Biochimique SA - Treatment for acute pain due to minor strains, sprains, and contusions.
• Flector (diclofenac epolamine) FDA Approval History

NovoLog (insulin aspart)

Labeling Revision Approved: January 26, 2007

• FDA Approves NovoLog Category Change for Use in Pregnant Women withType 1 Diabetes

Lialda (mesalamine)

Labeling Revision Approved: July 14, 2011

• Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History