Idiopathic Pulmonary Fibrosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-08-07FDA Approved: PIRFENIDONE — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for pirfenidone, a generic version of Esbriet, for the treatment of idiopathic pulmonary …
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FDA approval · 2023-08-07FDA Approved: PIRFENIDONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for a generic pirfenidone from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2023-08-07FDA Approved: PIRFENIDONE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for pirfenidone from Camber Pharmaceuticals (generic pirfenidone) for marketing, related to idio…
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FDA approval · 2023-05-31FDA Approved: PIRFENIDONE — Original Application (Apotex Corp.)
FDA approves Apotex Corp.'s original application for pirfenidone, a generic version of the IPF treatment.
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FDA approval · 2023-03-02FDA Approved: PIRFENIDONE — Supplemental Application (Accord Healthcare Inc.)
The FDA approved Accord Healthcare Inc.'s supplemental application to market a generic pirfenidone product for idiopathic pulmonary fibrosis…
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FDA approval · 2023-02-24FDA Approved: ESBRIET — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for ESBRIET (pirfenidone) submitted by Genentech, Inc.
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FDA approval · 2022-10-11FDA Approved: PIRFENIDONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for pirfenidone from Amneal Pharmaceuticals NY LLC, supporting a generic version of the drug.
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FDA approval · 2022-09-21FDA Approved: PIRFENIDONE — Original Application (Camber Pharmaceuticals, Inc.)
Camber Pharmaceuticals received FDA approval for a generic pirfenidone product via an Original Application (ANDA) to treat idiopathic pulmon…
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FDA approval · 2022-08-11FDA Approved: PIRFENIDONE — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a supplemental application for pirfenidone from Teva Pharmaceuticals, Inc., supporting a generic version of the drug.
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FDA approval · 2022-08-01FDA Approved: PIRFENIDONE — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved the original application for pirfenidone as a generic product manufactured by ScieGen Pharmaceuticals for idiopathic pulmonary …
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FDA approval · 2022-08-01FDA Approved: PIRFENIDONE — Original Application (Cipla USA Inc.)
FDA approved an original generic application for pirfenidone by Cipla USA Inc., making a generic version available for idiopathic pulmonary …
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FDA approval · 2022-07-19FDA Approved: PIRFENIDONE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved an original application for pirfenidone from ANI Pharmaceuticals, establishing a generic version of the antifibrotic for id…
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FDA approval · 2022-07-19FDA Approved: PIRFENIDONE — Original Application (Laurus Labs Limited)
FDA approved the original application for a generic pirfenidone (Laurus Labs Limited), enabling generic availability for idiopathic pulmonar…
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FDA approval · 2022-06-13FDA Approved: PIRFENIDONE — Original Application (Sandoz Inc)
The FDA approves Sandoz Inc's original application for pirfenidone, enabling a generic version of the drug to enter the market.
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FDA approval · 2022-05-24FDA Approved: PIRFENIDONE — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved an Abbreviated New Drug Application for pirfenidone (Novadoz Pharmaceuticals LLC), a generic version of the IPF therapy.
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FDA approval · 2022-05-20FDA Approved: PIRFENIDONE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's original application for pirfenidone, establishing a generic version of the antifibrotic medi…
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FDA approval · 2022-05-18FDA Approved: PIRFENIDONE — Original Application (Micro Labs Limited)
FDA approved a generic version of pirfenidone from Micro Labs Limited through an Original Application (ANDA) for idiopathic pulmonary fibros…
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FDA approval · 2022-04-28FDA Approved: PIRFENIDONE — Original Application (Sandoz Inc)
The FDA approved Sandoz Inc's original application for a generic pirfenidone product for treatment of idiopathic pulmonary fibrosis.
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FDA approval · 2022-03-25FDA Approved: PIRFENIDONE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original application for pirfenidone by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2022-02-11FDA Approved: ESBRIET — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Esbriet (pirfenidone) from Genentech, resulting in labeling changes for the product.
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FDA approval · 2022-01-25FDA Approved: PIRFENIDONE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved the original application for pirfenidone from Teva Pharmaceuticals, authorizing a generic version for idiopathic pulmonary fibr…
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FDA approval · 2022-01-25FDA Approved: PIRFENIDONE — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's generic pirfenidone as an original application for the treatment of idiopathic pulmonary fibrosis.
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FDA approval · 2022-01-03FDA Approved: PIRFENIDONE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved a generic version of pirfenidone (ANDA 212569) for idiopathic pulmonary fibrosis, manufactured by Amneal Pharmaceuticals NY LLC…
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FDA approval · 2019-09-06FDA Approved: OFEV — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)
FDA approved a supplemental application for OFEV (nintedanib) from Boehringer Ingelheim Pharmaceuticals, expanding its approved use.
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FDA approval · 2019-07-31FDA Approved: ESBRIET — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Esbriet (pirfenidone) filed by Genentech, Inc.