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Search Orphan Drug Designations and Approvals
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/
WebSearch Orphan Drug Designations and Approvals. FDA Home. Developing Products for Rare Diseases & Conditions. This page searches the Orphan Drug Product designation database. Searches may be run by...
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Public Identification of Orphan Drug Designation | FDA
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/public-identification-orphan-drug-designation
WebThe Food and Drug Administration (FDA) publishes the generic name and/or trade name of a drug on our website at Search Orphan Drug Designations and Approvals after we …
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Orphan Drugs | HRSA - Health Resources and Services …
https://www.hrsa.gov/opa/program-requirements/orphan-drug-exclusion
WebOrphan Drug Designation List. The Orphan Drug Designation List was updated and developed using the methodology referenced in About the Orphan Drug List. It should be …
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Top 20 orphan drugs by 2018 | Fierce Pharma
https://www.fiercepharma.com/special-report/top-20-orphan-drugs-by-2018
WebPandemic drug, shot and test makers Pfizer and Roche pen COVID awareness collab. Dec 27, 2022 11:00am.
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340B Drug Pricing Program Orphan Drugs Program Requirements
https://www.hhs.gov/guidance/document/340b-drug-pricing-program-orphan-drugs-program-requirements-1
WebThe Orphan Drug Designation List was updated and developed using the methodology referenced in About the Orphan Drug List. It should be used to govern the quarter July …
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Orphan Drugs | Official web site of the U.S. Health Resources
https://akastage-www.hrsa.gov/opa/program-requirements/orphan-drug-exclusion
WebThe Orphan Drug Designation List was updated and developed using the methodology referenced in About the Orphan Drug List. It should be used to govern the quarter April …
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Search Orphan Drug Designations and Approvals - Food and Drug
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=683
WebGeneric Name: Hemin. Trade Name: Panhematin. Date Designated: 03/16/1984. Orphan Designation: Amelioration of recurrent attacks of acute intermittent porphyria (AIP) …
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Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity …
https://www.biospace.com/article/releases/xeris-biopharma-announces-fda-grants-orphan-drug-exclusivity-for-recorlev-/
WebThe FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. This …
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PharmaTher Holdings Announces FDA Grant of Orphan Drug …
https://www.tipranks.com/news/press-releases/pharmather-holdings-announces-fda-grant-of-orphan-drug-designation-to-ketarx-ketamine-for-the-treatment-of-rett-syndrome
WebThis status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to …
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