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New Drug Approvals Archive - January 2007

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January 2007

January 12

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 (clobetasol propionate) FDA Approval History

January 16

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 (mesalamine) FDA Approval History

January 30

Vidaza (azacitidine)

New Dosage Form Approved: January 26, 2007

Vidaza (azacitidine) FDA Approval History

January 31

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 (diclofenac epolamine) FDA Approval History

January 31

NovoLog (insulin aspart)

Labeling Revision Approved: January 26, 2007

July 18

Lialda (mesalamine)

Labeling Revision Approved: July 14, 2011

Lialda (mesalamine) FDA Approval History