Food and Drug Administration (FDA)
NEWS
Despite Political Rhetoric, Some Drug Prices Jumped on July 1, Including Medicines on Shortage Lists
The beginning of July is when many companies increase the price on prescription medications in the U.S. This year’s price increases are higher than the same period last year.
Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.
Have you ever asked your doctor whether the drug they are prescribing you is FDA-approved for how they are prescribing it? When a doctor prescribes an FDA-approved drug for a disease or condition, age group, or dosage other than what it has been approved for, then it is called an unapproved, or “off-label,” use.
Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.
Gottlieb’s knowledge of the regulatory and political landscape will be a boon for Pfizer as it dives deeper into oncology.
Darzalex in combination with lenalidomide and dexamethasone was approved as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.
The U.S. Food and Drug Administration (FDA) gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults that express a specific biomarker.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
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