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NIX

NDA

PERMETHRIN | N019918 | MEDTECH PRODUCTS INC

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
Citizen Petition from Burroughs Wellcome Co. FDA-1990-P-0354 · 4 docket documents Burroughs Wellcome Co. filed this petition on December 19, 1990, requesting three years of marketing exclusivity for NIX (permethrin) Creme Rinse for over-the-counter marketing under its approved NDA, arguing that new clinical studies submitted in support of the OTC application provided essential sa	Other	2017-04-28	Partially Denied	Burroughs Wellcome Co.

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

Clinical Trials

33 trials from ClinicalTrials.gov, 26 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice NCT00244439	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	360	2005-12 → 2006-12
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice NCT00963508	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	403	2009-08 → 2010-03
Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma NCT03813069	Phase 2	Completed	London School of Hygiene and Tropical Medicine	64	2019-01-10 → 2019-12-23
Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice NCT00545753	Phase 3	Completed	ParaPRO LLC	558	2007-09 → 2008-05
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands NCT03236168	Phase 3	Completed	London School of Hygiene and Tropical Medicine	118	2017-08-01 → 2018-02-28
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice NCT00927472	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	254	2009-08 → 2010-06
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies NCT03973775	Phase 3	Completed	Saptalis Pharmaceuticals LLC	126	2018-04-10 → 2018-12-06
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.NCT02978508	Phase 3	Completed	Mayne Pharma International Pty Ltd	140	2016-11 → 2017-05
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies NCT02572986	Phase 3	Completed	Dr. Reddy's Laboratories Limited	250	2015-09 → 2016-08
Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice NCT00545168	Phase 3	Completed	ParaPRO LLC	480	2007-09 → 2008-05

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

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDPERMETHRIN BPC CIS:TRANS/25:75

DMF 117021995

SRIKEM LABORATORIES PVT LTDPERMETHRIN

DMF 280902014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPERMETHRIN

DMF 302432016

WAVELENGTH ENTERPRISES LTDPERMETHRIN

DMF 311902016

FMC CORPInactivePERMETHRIN

DMF 121451996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 17, 2002	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: May 2, 1990

No patent or exclusivity listings for this strength.