Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2010-01-08
2011-12-27
Padmanabhan, Sreeni (Department: 1627)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S354000, C514S345000
Reexamination Certificate
active
08084475
ABSTRACT:
The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
REFERENCES:
patent: 5310562 (1994-05-01), Margolin et al.
patent: 5518729 (1996-05-01), Margolin et al.
patent: 5716632 (1998-02-01), Margolin et al.
patent: 7407973 (2008-08-01), Ozes et al.
patent: 7566729 (2009-07-01), Bradford et al.
patent: 2006/0110358 (2006-05-01), Hsu et al.
patent: 2007/0053877 (2007-03-01), Crager et al.
patent: 2007/0054842 (2007-03-01), Blatt et al.
patent: 2007/0072181 (2007-03-01), Blatt
patent: 2007/0092488 (2007-04-01), Strieter et al.
patent: 2007/0117841 (2007-05-01), Ozes et al.
patent: 2007/0172446 (2007-07-01), Blatt
patent: 2007/0203202 (2007-08-01), Robinson et al.
patent: 2007/0203203 (2007-08-01), Tao et al.
patent: 2008/0019942 (2008-01-01), Seiwert et al.
patent: 2008/0194644 (2008-08-01), Bradford
patent: 2008/0287508 (2008-11-01), Robinson et al.
patent: 2009/0170804 (2009-07-01), Phillips et al.
patent: 2009/0197923 (2009-08-01), Bradford
Kroon 2007, Drug Interactions with smoking. Am J Health-Syst Pharm, vol. 64, pp. 1917-1921.
Branch et al. 2000, In vivo modulation of CYP enzymes by quinidine and rifampin. Clinical Pharmacol Ther, vol. 68, pp. 401-411.
Shionogi & Co., Ltd., Pirespa Tablet Packaging Label, Prepared in Oct. 2008.
Azuma, et al., Am J Respir Crit Care Med, 117:1040-1047 (2005).
English translation of collection of Review Reports from Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of Shionogi & Co., Ltd.'s Pirespa Tablet product (dates, Sep. 16, 2008, Sep. 8, 2008, Aug. 20, 2008, and Jul. 4, 2008) (http://www.pmda.go.jp/english/service/pdf/Pirespa-Pirfenidone.pdf).
Taniguchi, et al.,ERJ Express, published online as doi:10.1183/09031936.00005209 on Dec. 8, 2009.
Food and Drug Administration Center for Drug Evaluation and Research, Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting Transcript (Tuesday, Mar. 9, 2010), published at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM208806.pdf.
Pirfenidone NDA 22-535 Pulmonary-Allergy Drugs Advisory Committee Mar. 9, 2010, slide deck (InterMune, Inc.), published at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM206399.pdf.
Pulmonary-Allergy Drugs Advisory Committee Meeting, Pirfenidone Capsules, NDA 22-535, S-000, Mar. 9, 2010, slide deck (U.S. Food and Drug Administration), published at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM206398.pdf.
Correspondence received from FDA.
Landi et al., Human cytochrome P4501A2, Metabolic Polymorphisms and Susceptibility ot Cancer, Chapter 16, pp: 173-195 (1999).
Jeppensen et al., Dose-dependent inhibition of CYP1A2, CYP2C19 and CYP2D6 by citalopram, fluoxentine, fluvoxamine and paroxetine,Eur. J. Clin. Pharmacol. 51(1): 73-8 (1996).
Examination Report for European Patent Application No. 10 250 378.6, European Patent Office, dated Jun. 11, 2010.
Eldon et al., Lack of effect of withdrawal from cigarette smoking on theophylline pharmacokinetics, J. Clin. Pharmacol., 27:221-5 (1987).
Faber et al., Time response of cytochrome P450 1A2 activity on cessation of heavy smoking, Clin. Pharmacol. Ther., 76:178-84 (2004).
Zevin et al., Drug interactions with tobacco smoking: an update, Clin. Pharmacokinet., 36(6):425-38 (1999).
Bradford Williamson Ziegler
Szwarcberg Javier
Bendrick John
Intermune, Inc.
Marshall & Gerstein & Borun LLP
McMillian Kara R
Padmanabhan Sreeni
LandOfFree
Pirfenidone therapy and inducers of cytochrome P450 does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Pirfenidone therapy and inducers of cytochrome P450, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pirfenidone therapy and inducers of cytochrome P450 will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4294310