Viewing data from:

VELTIN

NDA

CLINDAMYCIN PHOSPHATE; TRETINOIN | N050803 | ALMIRALL LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Actavis, Inc. - Citizen Petition FDA-2011-P-0606 · 4 docket documents Actavis, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Veltin (clindamycin phosphate and tretinoin) Topical Gel, 1.2%/0.025%, NDA 50803, as a second reference-listed drug to enable the submission of an ANDA for a g	505(q)	2011-09-01	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

5 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea NCT00823901	Phase 2/3	Completed	Massachusetts General Hospital	83	2009-02 → 2010-10
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris NCT01047189	Phase 4	Completed	Wake Forest University	26	2009-03 → 2009-10
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne NCT01422785	Phase 4	UNKNOWN	Zeichner, Joshua, M.D.	40	2011-07
Efficacy & Safety of Clindamycin and Tretinoin in Acne NCT01111994	Phase 4	UNKNOWN	Callender Center for Clinical Research	30	2009-11 → 2010-04
Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris NCT01448733	Phase 4	UNKNOWN	Zeichner, Joshua, M.D.	20	2011-07 → 2011-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 20, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.2%;0.025%

RLDAB2

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 16, 2010

No patent or exclusivity listings for this strength.