Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2011-03-22
2011-03-22
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, C514S640000, C514S646000
Reexamination Certificate
active
07910610
ABSTRACT:
The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
REFERENCES:
patent: 5310562 (1994-05-01), Margolin
patent: 5518729 (1996-05-01), Margolin
patent: 5716632 (1998-02-01), Margolin
patent: 7407973 (2008-08-01), Ozes et al.
patent: 7566729 (2009-07-01), Bradford et al.
patent: 7635707 (2009-12-01), Bradford et al.
patent: 7696236 (2010-04-01), Bradford
patent: 7728013 (2010-06-01), Blatt et al.
patent: 2006/0110358 (2006-05-01), Hsu
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: 2008/0003635 (2008-01-01), Ozes 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: 2009/0191265 (2009-07-01), Radhakrishnan et al.
patent: 2009/0197923 (2009-08-01), Bradford
patent: 2009/0318455 (2009-12-01), Kossen et al.
patent: 2010/0152250 (2010-06-01), Radhakrishnan et al.
Aloxi® (palonosetron) package insert, Rev. Feb. 2008 (“Palonosetron package insert”).
Azuma et al., Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am. J. Respir. Crit. Care Med. 171: 1040-1047 (2005).
BuSpar® (buspirone HCI, USP) package insert, Mar. 2007.
Clozaril® (clozapine) package insert, Jan. 2010.
Correspondence received from FDA, 2010.
Dolophine® Hydrochloride (methadone hydrochloride) package insert, Sep. 2009.
European search report from EP 10250379.4 dated May 17, 2010.
FDA Briefing Information for the Mar. 9, 2010 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (Contains the Clinical Briefing Document (Banu Karimi-Shah, M.D., Clinical Reviewer, Division of Pulmonary and Allergy Products, NDA 22-535) beginning on page 21), published at <http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203081.pdf>.
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>.
Hemeryck et al. 2002. Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: An update, Current Drug Metabolism, vol. 3, pp. 13-37.
Inderal® (propranolol hydrochloride capsule, extended release) package insert, Nov. 2007.
Inderal® (propranolol hydrochloride, long-acting capsules) package insert, Nov. 2007.
Jeppesen et al., “Dose-dependent inhibition of CYPIA2, CYP2C19 and CYP2D6 by citalopram, fluoxetine, fluovaxamine and paroxetine,” European Journal of Clinical Pharmacology, 41(1):73-78 (1996).
Landi, et al., “Human cytochrome P4501A2.” IARC Scientific Publications 148:173-195 (1999).
Lexotan® (bromazepam) package insert, Feb. 2007.
Malarone® (mexiletine hydrochloride, USP) package insert, 2008.
Mexitil® (mexiletine hydrochloride monohydrate) package insert, 2003.
Naropin® (ropivacaine hydrochloride monohydrate) package insert, Nov. 2008.
Odansetron product information from the UK Medicines and Healthcare Products Regulatory Agency (“Odansetron UK product information”), Mar. 14, 2007.
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>.
Quinidine Gluconate package insert, 2002.
Remington's: the Science and Practice of Pharmacy, Nineteenth Edition, vol. 1, p. 806, 1985.
Thioridazine Hydrochloride package insert, May 2009.
Tofranil (imipramine hydrochloride) package insert, Aug. 2007.
Zofran® (odansetron) package insert (“Odansetron package insert”), Apr. 2002.
Zyprexa® (olanzapine) package insert, Rev. Jan. 27, 2010 (“Olanzapine package insert”).
Taniguchi, et al., “Pirfenidone in idiopathic pulmonary fibrosis,” Eur Respir J, 35:821-829 (2010) (Available online Dec. 8, 2009).
Shionogi & Co., Ltd., Pirespa Tablet Packaging Label, Prepared in Oct. 2008.
Shionogi & Co., Ltd., Pirespa Tablet Report on the Deliberation Results, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (Sep. 16, 2008).
Intermune, Pirfenidone Briefing Document, (Publication date Mar. 9, 2010).
Bradford Williamson Ziegler
Szwarcberg Javier
Bendrick John A.
Intermune, Inc.
Marshall & Gerstein & Borun LLP
McMillian Kara R
Padmanabhan Sreeni
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