Search court records on patent:(9517219) - not party Tyler Liu, page 2

All Courts
Federal Courts
Bankruptcies
PTAB
ITC

Filters

Display dockets
Display documents
- Decisions and Orders
- Exhibits
- Briefs and Motions
- Pleadings
- x Reset Selection

Like full text docket searches?

Get docket alerts, perform legal research, get updates of major decisions and orders, use our advanced analytics, and more. Request a Demo or create your account.

Displaying 9-20 of 20 results

sorted by

Review Medical Reviews

Document ACZONE, 207154, Review Medical Reviews (Orange Book Feb. 24, 2016)

For this 505(b)(1) application, based on the data submitted from the six trials in the clinical development program, safety and efficacy of ACZONE ® (dapsone) Gel, 7.5% have been established for the topical treatment of acne vulgaris in patients 12 years of age and older.

A proposal for the PMR is as follows: Conduct an open-label study to assess safety, pharmacokinetics, and treatment effect of ACZONE® Gel, 7.5% in 100 pediatric subjects age 9 to 11 years 11 Reference ID: 3875816 Clinical Review Patricia C. Brown, MD

Formulations Brand Name Generic Name Owner moderate acne .35 mg Norgestlmate .025 mg/ ethinyl estradiol Orhto-Cyden Orhto Tri- cyclen Jansse" Pharms vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche Compiled by reviewer from website “Drugs at FDA” accessed October 28, 2015 2.3 Availability of Proposed Active Ingredient in the United States ACZONE® (dapsone) Gel, 5% was approved July 7, 2005 (NDA 21794).

The site of Dr. Forsha was issued a Form FDA 483 noting deficiencies including a lack of adherence to the protocol, and inadequate documentation of adverse events (AEs), concomitant medications, informed consent or assent, and drug accountability.

17.6 ± 6.7 186 ± 71 379 ± 142 The clinical pharmacology reviewer explains that: “Relative to Aczone Gel, 5%, daily systemic exposure of dapsone, defined by the geometric mean ratio for maximum plasma concentration (Cmax) and area under the concentration-time curve from time 0 to 24 hours postdose (AUC0-24), was approximately 28.6% and 28.7% lower for formulation 11080X, respectively.

Cite Document

Analyze

Search within this case
Find cases with Party
- Almirall

Letter

Document ACZONE, 207154, Letter (Orange Book Feb. 24, 2016)

Attention: Jeremy McCumber, MS Director, Global Regulatory Affairs 2525 Dupont Drive P.O.

This new drug application provides for the use of ACZONE (dapsone) Gel, 7.5% for the topical treatment of acne vulgaris in patients 12 years of age and older.

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients unless this requirement is waived, deferred, or inapplicable.

To do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or mock-up form with annotated references, and the package insert, Medication Guide, and patient PI (as applicable) to: OPDP Regulatory Project Manager Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion 5901-B Ammendale Road Beltsville, MD 20705-1266

As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package insert, at the time of initial dissemination or publication, accompanied by a Form FDA 2253.

Cite Document

Analyze