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Drugmakers are slow to prove medicines that got a fast track to market really work
22 Jul 2022 17:34 GMT
… took a pharmaceutical company to … studies. The drug called Proamatine raises blood pressure … . But the FDA deemed the drugmaker';s postmarketing trials "inconclusive,… one treatment, but it stopped working within a few months. Her doctors …
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Alembic Pharmaceuticals receives FDA approval for Midodrine Hydrochloride tablets
22 Jan 2021 08:45 GMT
… to the reference listed drug product (RLD), ProAmatine tablets, 2.5 mg … for the treatment of symptomatic orthostatic hypotension (OH),
Alembic Pharmaceuticals Limited announced … the US Food & Drug Administration (US FDA) for its abbreviated new …
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Inspector General: 104 Accelerated Approvals Have Incomplete Confirmatory Trials
01 Oct 2022 04:21 GMT
… benefit over existing treatments before the confirmatory trials are finished. … drug is a topical antimicrobial for burns.
• Takeda’s Proamatine … spent $14 billion and Medicare Part C spent $6 … in a confirmatory trial when the treatment is already available,” …
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midodrine
24 Nov 2024 00:06 GMT
… the use of this drug.
Call your doctor for medical advice about serious … -the-counter (OTC) medications such as cold remedies or diet aids can … ;drug/proamatine-orvaten-midodrine-342442#0
https://www.accessdata.fda.gov/drugsatfda …
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Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
24 Aug 2023 16:56 GMT
… randomized, double-blinded clinical trial intended to describe and … endpoints related to the drug (e.g., blood … whichever is longer. The trials will monitor antibody response ( … 47;2022
Proamatine (midodrine hydrochloride)
For the treatment of symptomatic …
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Ongoing | Non-malignant Hematology, Neurological Disorders, and Other Indications Accelerated Approvals
12 Jan 2022 07:18 GMT
… vosoritide-treated trial population should include … is longer. The trials will monitor antibody … smallpox vaccination: eczema vaccinatum progressive vaccinia severe generalized vaccinia vaccinia …
Proamatine (midodrine hydrochloride)
For the treatment of …