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Journal of Drugs in Dermatology,  June, 2003  

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New Drug Application 19-941/S14, S15

Approval Date:        1/27/03
Name:                 EMLA Anesthetic Disc
Applicant:            AstraZeneca LP
OTC/RX status:        RX
Indication of Use:    Topical anesthetic

New Drug Application 21-470

Approval Date:        12/24/02
Name:                 Finacea Gel
Active Ingredient:    Azelaic Acid 15%
Applicant:            Berlex Drug Development
                      and Technology
OTC/RX:               RX
Indication of Use:    Topical treatment of rosacea

Abbreviated New Drug Application 75-209

Approval Date:        1/21/03
Name:                 Loratidine
Dose:                 10 mg tablets
Applicant:            Geneva Pharmaceuticals, Inc.
Type:                 Generic approval of Claritin
OTC/RX:               OTC
Indication of Use:    Treatment of allergic rhinitis

New Drug Application 50-88

Approval Date:        12/4/02
Name:                 Mupirocin Ointment 2%
Applicant:            Clay-Park Labs, Inc.
Type:                 Generic approval of Bactroban
OTC/RX:               RX
Indication of Use:    Topical treatment of
                      impetigo; eradication of
                      nasal colonization of
                      methicillin-resistant
                      S. aureus.

New Drug Application 21-142/S3, S4

Approval Date:        12/20/02
Name:                 Olux
                      (clobetasol propionate foam)
Dosage:               0.05%
Applicant:            Connetics Corporation
Type:                 Expanded labeling
OTC/RX:               RX

Indications of Use/Expanded labeling: Added approval for the
short-term topical treatment of mild to moderate plaque-type
psoriasis of non-scalp regions.

New Drug Application 19-822/S-006

Approval Date:        1/9/03
Name:                 Pre-Scrub II
Active Ingredient:    4% chlorhexidine
                      gluconate solution
Applicant:            Biomed Systems, Inc.
OTC/RX:               RX
Indications of Use:   Surgical hand scrub,
                      hand wash, hand rinse,
                      skin wound cleanser

Abbreviated New Drug Application 75-181

Approval Date:        12/23/2002
Name:                 Prednisolone Sodium
                      Phosphate
Dosage:               5mg/5cc Oral solution
Applicant:            WE Pharmaceuticals, Inc
RX/OTC:               RX
Indications of Use:   Glucocorticoids exert
                      anti-inflammatory effects

New Drug Application 21-023

Approval Date:        12/23/02
Name:                 Restasis Ophthalmic Emulsion
Active Ingredient:    Cyclosporine
Dose:                 0.05%
RX/OTC:               RX

New Drug Application 21-478

Approval Date:        12/30/02
Name:                 Zovirax Cream
Active Ingredient:    Acyclovir
Applicant:            GlaxoSmithKline
OTC/RX:               RX

New Drug Application

Approval Date:        1/31/03
Name:                 Amevive (alefacept)
Applicant:            Biogen
Type:                 Biologic
OTC/RX:               RX
Indication of Use:    First biologic agent
                      approved for psoriasis

Abbreviated New Drug Application

Approval Date:        2/18/2003
Name:                 Lidocaine Jelly, 2%
Type:                 Generic Approval of
                      Xylocaine Jelly, 2%
OTC/RX:               OTC
Indications of Use:   Topical anesthetic

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