Elmiron Timeline (Pentosan Polysulfate Sodium)
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Aug. 7, 1985
Elmiron was granted orphan drug status. An orphan drug is one intended to treat a rare disease; usually, it’s the only drug on the market for that disease. The company on the orphan drug designation was the Alza Corporation.
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1986
Elmiron was made available on a compassionate use basis. This means that it could be prescribed to seriously ill patients even though it had not yet been approved.
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Jan. 24, 1989
The trademark for Elmiron was registered with the United States Patent and Trademark Office.
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July 31, 1989
A patent for Elmiron was filed with the United States Patent and Trademark Office.
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June 11, 1991
Baker Cummins Pharmaceuticals Inc. submitted a New Drug Application for Elmiron to the United States Food and Drug Administration (FDA).
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June 25, 1991
FDA sent a letter to Baker Cummins Pharmaceuticals Inc. acknowledging receipt of the New Drug Application for Elmiron.
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Nov. 8, 1991
A mathematical statistician with the FDA, James Gerbert, Ph.D., indicated that the “evidence of [the effectiveness] of Elmiron for the treatment of interstitial cystitis [was] very weak.”
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Nov. 15, 1991
A review chemist with the FDA, Patricia Stewart, concluded that the New Drug Application for Elmiron was “not approvable from the standpoint of manufacturing and controls.”
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Dec. 20, 1991
James E. Wilson, Ph.D., at the FDA concluded that the application was “approvable from the standpoint of pharmacology with changes in the labeling.”
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Jan. 27, 1992
Daniel Gordin, Ph.D., with the Pharmacokinetics Evaluation Branch of the FDA noted a discrepancy in the chemistry.
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Feb. 18, 1992
Acting Director of the FDA Wiley A. Chambers, M.D., concluded, “the application [was] not recommended for approval.” Chambers recommended that additional information be addressed if the application were to be resubmitted.
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Feb. 25, 1992
Gordin stated that “the bio-data submitted in [the Elmiron] New Drug Application has not adequately described the bioavailability/pharmacokinetics of [Elmiron] and is not adequate to support its approval and its labeling.”
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Oct. 22, 1992
Peter Vaccari at the FDA Office of Orphan Products Development sent a memorandum to FDA Acting Supervisory Consumer Safety Officer Jim Cheever regarding designating Elmiron as an orphan product and requesting to update their information management system to reflect the drug as an orphan product.
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Nov. 9, 1992
Vice President of Regulatory Affairs at Baker Norton Pharmaceuticals Inc. Edward R. Gubish, Ph.D., sent a letter to FDA Director Wiley Chambers advising the FDA that Baker Cummins had undergone an administrative name change to Baker Norton Pharmaceuticals Inc.
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Dec. 10, 1992
Baker Norton amended the New Drug Application.
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Dec. 18, 1992
The FDA acknowledged receipt of the amended New Drug Application dated Dec. 10, 1992.
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Jan. 19, 1993
A patent for Elmiron was granted by the United States Patent and Trademark Office.
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Jan. 27, 1993
The FDA issued a not-approvable letter.
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March 19, 1993
The FDA and Baker Norton Pharmaceuticals Inc. held a meeting to discuss the Jan. 27, 1993, not-approvable letter and requested that Baker Norton Pharmaceuticals study higher doses, specify the primary endpoints, and reanalyze clinical trial data.
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April 9, 1993
FDA Chemist Kermit M. Floyd recommended non-approvability of the application.
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July 7, 1993
Baker Norton amended the New Drug Application.
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July 9, 1993
FDA Acting Division Director Patricia Love, M.D., prepared an internal memorandum to the FDA indicating that some of the responses in the July 7, 1993, amended NDA were adequate but there were still major deficiencies.
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July 20, 1993
At the Pharmacokinetics Evaluation Branch of the FDA, Gordin indicated that the sponsor resubmitted information that was found to be inadequate.
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July 21, 1993
The FDA acknowledged receipt of the amended New Drug Application dated July 7, 1993.
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Aug. 3, 1993
Patricia Stewart, a review chemist with the FDA, concluded that the application was “not approvable from the standpoint of manufacturing and controls.”
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Sept. 8, 1993
Stewart noted that the “application is not approvable as yet and awaiting response to deficiencies.”
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Sept. 30, 1993
Elizabeth A. Turney, M.S., a biomedical statistician with the FDA, concluded that the applicant had failed to provide two independent, adequate, and well-controlled trials to support their claim that Elmiron was effective in the treatment of interstitial cystitis.
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Nov. 9, 1993
A medical reviewer at the FDA, Paul Waymack, M.D., concluded that the sponsor’s comments failed to fully address the request made by the FDA in correspondence dated Jan. 27, 1993.
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Jan. 3, 1994
Dr. Nancy Smith and Dr. Ralph Harkins, medical reviewers at the FDA, sent a memorandum to FDA Acting Division Director Patricia Love, M.D., in which they indicated that the sponsor was unwilling to perform a withdrawal study and an additional well-controlled trial should be required.
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Feb. 11, 1994
An amended New Drug Application was submitted.
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Feb. 14, 1994
Love recommended that the New Drug Application remain not approvable, as there were chemistry and environmental assessment deficiencies that should be added to the non-approval letter.
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Feb. 28, 1994
The FDA acknowledged receipt of the amended New Drug Application dated Feb. 11, 1994.
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March 7, 1994
Paul Waymack, M.D., a medical reviewer at the FDA, indicated that a full report would be required to determine if the study had truly documented safety at the dosages proposed for treating patients with interstitial cystitis.
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April 13, 1994
Review chemist Stewart concluded that “there are still a few chemistry problems that should be resolved before final approval.”
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May 24, 1994
Norman A. See, Ph.D., an FDA reviewing pharmacologist, had a call with a Dr. Kamul Abdul at Baker Norton about the fact that much of the existing data was old. It was agreed that Baker Norton should repeat its studies.
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Aug. 29, 1994
Waymack sent a letter to Love indicating that the number of patients in each trial was insufficient to generate definitive proof of effectiveness.
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Aug. 31, 1994
Baker Norton Vice President Jane Hsiac, Ph.D., sent a letter to Marlene Haffner, M.D., at the FDA regarding outstanding concerns about the effectiveness of Elmiron.
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Sept. 19, 1994
FDA mathematical statistician Nancy D. Smith, Ph.D., recommends that Baker Norton be encouraged to do one large, multicenter study involving none of the investigators who participated in earlier studies.
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Oct. 28, 1994
The FDA issued a second not-approvable letter.
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Feb. 16, 1995
The FDA held a meeting with Baker Norton to discuss the October not-approvable letter.
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March 27, 1995
Waymack indicated that the New Drug Application failed to provide adequate evidence from two well-controlled trials demonstrating that Elmiron was safe and effective in the treatment of the disease and noted that the two studies performed were flawed in that they had multiple investigators in both trials.
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March 30, 1995
Cheever of the FDA spoke with Ed Mitchell of the regulatory affairs department at Baker Norton to request further information regarding existing data.
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June 29, 1995
Love sent a letter to Mitchell regarding discrepancies noted in their meeting.
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Aug. 31, 1995
The New Drug Application was amended.
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Sept. 12, 1995
Stewart indicated that the “application was approvable from a chemistry standpoint.”
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Sept. 19, 1995
The FDA acknowledged receipt of the amended New Drug Application dated Aug. 31, 1995.
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Oct. 12, 1995
FDA Consumer Safety Officer Susan Cusack informed Baker Norton that the chemistry review of the amendment was complete.
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Oct. 23, 1995
Cusack spoke with Steve Viti in the regulatory affairs department at Baker Norton to discuss that the labeling needed further revision.
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Nov. 30, 1995
Cusack spoke with Viti to obtain authorization to discuss Elmiron with another individual.
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Dec. 5, 1995
Stewart concluded that the “application may be approved from a chemistry standpoint.”
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Dec. 8, 1995
Cusack spoke with Viti to ask questions about the Compassionate Use Study.
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Dec. 10, 1995
The New Drug Application was amended.
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Jan. 19, 1996
David J. Lee, Ph.D., a medical reviewer with the FDA, recommended that they not approve Elmiron from a biopharmaceutical perspective, as the bio-data submitted was not adequate to support its approval as well as support its labeling.
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Jan. 23, 1996
Cusack spoke with Viti regarding a request for additional information.
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Feb. 12, 1996
Stewart indicated that the amendment dated Dec. 10, 1995, did not specifically answer each question but the sponsor did present sufficient information to respond satisfactorily to the deficiencies.
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Feb. 23, 1996
Love submitted an internal memorandum to the FDA indicating that Baker Norton had submitted sufficient safety and effectiveness data for Elmiron to be approvable.
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Feb. 29, 1996
An Adverse Events Study looked at incidents associated with Elmiron.
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March 1, 1996
Elmiron was finally approved by the FDA. Baker Norton was the sponsoring company on the FDA approval letter. Baker Norton was a subsidiary of the Ivax Corporation.
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April 10, 1996
FDA statistician Ruthanna C. Davi showed adverse events being reported by Elmiron patients, including nervous system problems in 3.57% of females.
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June 13, 1996
FDA acknowledged receipt of an amended New Drug Application dated April 10, 1996.
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Sept. 16, 1996
Lee and FDA Deputy Director John Hunt commented that the amendment on April 10, 1996, did not adequately address the deficiencies previously indicated for Elmiron. The application was not acceptable from a clinical pharmacology/biopharmaceutical perspective.
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Sept. 20, 1996
The FDA determined that pediatric studies were not needed for Elmiron.
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Sept. 23, 1996
Division Director Brief Comment mentioned that the sponsor was asked to revise the labeling and submit additional safety data.
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Sept. 26, 1996
The FDA approved the application for Elmiron and requested final printed labeling.
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Oct. 6, 1997
Alza acquired the rights to Elmiron from Baker Norton.
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March 27, 2001
Johnson & Johnson issued a news release that Johnson & Johnson was to merge with the Alza Corporation.
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June 22, 2001
Johnson & Johnson acquired the Alza Corporation.
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Nov. 8, 2001
An FDA letter to the Alza Corporation approved a New Drug Application for the removal of the cotton filler used to package Elmiron capsules.
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Sept. 26, 2003
Elmiron’s orphan drug exclusivity expired.
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Aug. 24, 2004
The FDA approved a package insert change.
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Jan. 26, 2006
Teva issued a news release announcing that they had completed acquisition of Ivax.
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Feb. 1, 2006
Ivax and Teva merged.
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Sept. 20, 2006
The FDA approved a product labeling change.
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July 24, 2008
The FDA approved a product labeling change.
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Dec. 12, 2008
The FDA approved a product labeling change.
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Jan. 19, 2010
The Elmiron patents expired. However, no generic was ever marketed in the United States.
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Jan. 15, 2015
Orphan designation was granted by the European Commission to Dr. Ulrich Granzer in Germany for Elmiron for the treatment of interstitial cystitis.
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Nov. 4, 2017
Elmiron was withdrawn in Europe from the list of designated orphan medicinal products on request of the sponsor.
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June 27, 2019
The European Medicines Agency recommended an update for Elmiron to warn about the risk of pigmentary maculopathy, particularly in patients taking Elmiron long-term.
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June 16, 2020
Janssen Pharmaceuticals makes a dramatic change to the Elmiron patient labeling on units sold within the United States. The newly revised patient label, approved by the FDA on June 16, 2020, now warns of “retinal pigmentary changes.” Retinal pigmentary changes could lead to severe and permanent eye injuries such as full or partial blindness, difficulty in adjusting to light changes, and difficulty reading. These eye problems do not improve should the patient discontinue taking Elmiron.
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