Drugs
FDA has issued Adamis Pharmaceuticals a second Complete Response Letter (CRL) on an NDA for epinephrine injection USP pre-filled single dose syringe product for the emergency treatment of acute anaphylaxis. The NDA was resubmitted earlier this year to address issues raised by a CRL issued 3/2015. That letter
Drugs
The DC Circuit Court of Appeals has upheld a lower court ruling that found FDA was correct in approving a Sandoz ANDA for a generic copy of Spectrum Pharmaceuticals’ Fusilev (levoleucovorin) despite orphan drug exclusivity on a use for which Sandoz had not sought approval. Pursuant to FDA regulations, Sandoz’
Drugs
FDA has issued a drug safety alert to warn consumers about the risk of serious bleeding when using over-the-counter, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. “These widely used products already contain warnings about this bleeding risk on their labels; however,
Drugs
FDA has approved an Allergan NDA for Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, indicated for treating hypertension to lower blood pressure. The company says the product is the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the U.S. Approval
Drugs
Joint comments from the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council have raised concern about a proposed biosimilarity statement recommended in a draft guidance on Labeling for Biosimilar Products because they say it is not only unnecessary but also may be confusing to patients and healthcare providers. The recommendations
Drugs
FDA has denied a Public Citizen petition that urged the agency to remove from the market Cypress Bioscience/Forest Laboratories’ Savella (milnacipran). The 1/20/2010 citizen petition said the drug, approved 1/14/09 for managing fibromyalgia in adults, has highly questionable clinical efficacy and has been found in
Drugs
FDA has granted Escend Pharmaceuticals an orphan drug designation for ES-3000 and its use for treating chronic myeloid leukemia (CML). ES-3000 is an orally bioavailable small molecule which ablates leukemic stem cells by reducing β-catenin expression through a novel mechanism of action, according to the company. The
Drugs
A new study says that many surrogate endpoints used to support most new cancer drugs approved by FDA lack formal empirical verification of the surrogate-survival association’s strength, and this practice should be reconsidered. Published in the June issue of Mayo Clinic Proceedings, the study questions whether the agency
Drugs
FDA has granted HedgePath Pharmaceuticals an orphan drug designation for SUBA-itraconazole capsules for treating patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) with its oral formulation of SUBA-Itraconazole capsules. BCCNS results from a genetic mutation that causes the Hedgehog pathway to function improperly, leading to the chronic formation
Drugs
Sens. Michael Bennet (D-CO) and Orrin Hatch R-UT) say they will attach their bill to create a new antibiotic drug approval pathway as an amendment to the National Defense Authorization Act for Fiscal Year 2017. Their Promise for Antibiotics and Therapeutics for Health (PATH) act would permit FDA
Drugs
FDA has issued a draft ICH harmonized guidance, E18 Genomic Sampling and Management of Genomic Data, that to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The document is intended to facilitate genomic studies implementation by enabling a common understanding of critical parameters for
Biologics
A coalition of 10 patient advocacy and research groups, including the Cystic Fibrosis, Muscular Dystrophy and National Patient Advocate foundations, the National MS Society, and the National Organization for Rare Disorders, say they oppose provisions in the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW Act)
Drugs
FDA says it is investigating reports of serious burns and potential permanent scarring in users of NuPathe’s battery-powered Zecuity (sumatriptan iontophoretic transdermal system) patch, indicated for treating acute migraines with or without aura in adults. “We are investigating the cause and extent of these serious side effects and
Drugs
FDA has granted Viamet Pharmaceuticals fast track status for VT-1129 for treating cryptococcal meningitis, a life-threatening fungal infection of the membranes covering the brain and spinal cord. Previously, the inhibitor of fungal CYP51 received orphan drug and qualified infectious disease product designations from the agency. Cryptococcal meningitis is
Drugs
In an effort to streamline the process doctors use to request expanded access (compassionate use) to investigational drugs and biologics for specific patients, FDA has released a new, much shorter Individual Patient Expanded Access Investigational New Drug Application, that the agency says should only take doctors 45 minutes to complete.
Drugs
Two researchers who were on the Institute of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies say there are steps that should be taken to improve the usefulness of biomarkers as part of precision medicine. Writing in a New England
Drugs
Attorney James Beck (Reed Smith) says that FDA’s extension of the comment period for its proposed generic drug labeling rule until 4/2017, after the upcoming presidential election, means that “for all practical purposes … the proposed rule is dead.” In an online blog post, Beck says that the law
Drugs
The AIDS Healthcare Foundation (AHF) says that FDA and Congress should investigate AIDS drug manufacturer Gilead Sciences for potential patent manipulation and antitrust violations. AHF says the company demonstrated “bald-faced greed” and “disregard for patient safety” in its development of TAF (tenofovir alafenamide fumarate), which can work at a
Drugs
CDER Office of Compliance manufacturing quality guidance and policy staff director Paula Katz says that three key elements in a drug company’s response to a data integrity Warning Letter are a comprehensive evaluation, risk assessment, and remediation and a management strategy. Speaking at a Parenteral Drug Association Manufacturing Science
Drugs
FDA has issued Teva Pharmaceutical Industries a Complete Response Letter on its NDA for SD-809 (deutetrabenazine) tablets for treating chorea-associated Huntington disease. The agency has asked Teva to examine blood levels of certain metabolites, according to the company. “These metabolites are not novel, and are the same seen
Drugs
The New Jersey federal court has granted an FDA motion seeking dismissal of a case brought against it by Health Science Funding, which developed and markets as a medical food Prastera, a pharmaceutically pure dehydroepiandrosterone product. The company typically sells Prastera as a dietary supplement for women with lupus. In
Drugs
FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the