Pipeline previews | Journal of Drugs in Dermatology | Find Articles at BNET Journal of Drugs in Dermatology , June, 2003 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.
