Drugs
FDA has released a list of 40 angiontensin II receptor blockers (ARBs) for which the agency has reached the conclusion that they do not contain any known nitrosamine impurities. In a statement linking to the list and other documents, FDA commissioner Scott Gottlieb and CDER director Janet Woodcock say they
Drugs
FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) capsules and their use in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients. The drug was initially approved in 2015 for treating certain women
Drugs
FDA has accepted for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonist for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The agency 2/2018 rejected the submission, citing concern about
Drugs
FDA has extended by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The extension is necessary for FDA to review a agency-requested data submission, according
FDA Policy/General
A Health Affairs article assesses FDA commissioner Scott Gottlieb’s nearly two years in office in terms of his efforts to advance policy in three areas relating to prescription drugs, and then looks ahead to how the agency may change under Ned Sharpless. The three drug policy areas considered are
FDA Policy/General
Outgoing FDA commissioner Scott Gottlieb, who was a resident fellow at the American Enterprise Institute (AEI) conservative think tank before being named to head FDA, is returning to AEI to focus on drug prices. In an interview with the Washington Post, Gottlieb said he is interested in trying to determine
Drugs
FDA has cleared a Magstim 510(k) to include intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder with its Horizon TMS Therapy system. The clearance allows Magstim to market the three-minute iTBS protocol, along with current options for standard repetitive Transcranial Magnetic Stimulation (TMS), which
Drugs
The American Association of Pro-Life Obstetricians and Gynecologists and the American College of Pediatricians are petitioning FDA to restore and strengthen elements of the Mifeprex (mifeprostol) regimen and prescriber requirements approved in 2000 and retain the Mifeprex REMS limiting dispensing of the drug to patients in clinics, medical offices,
Drugs
FDA has approved its first “Parallel Systems REMS” as part of the approval of four generic versions of Gilead’s Letairis (ambrisentan) for treating pulmonary arterial hypertension. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that FDA explained that three generic manufacturers of
Drugs
The Association for Affordable Medicines says the recommendations in an FDA draft guidance on Risk Evaluation and Mitigation Strategy (REMS) assessment, reporting, and survey methodologies are easier to implement in a brand REMS context and will be much more difficult to employ for a single, shared system REMS or separate
Drugs
FDA has released its 2019 priorities to improve the quality of drug compounding. In a statement from FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram, the agency says it will use funds in the 2019 budget to lay the groundwork for a Center of Excellence on Compounding for Outsourcing
Drugs
An 8/13-8/29/18 FDA inspection at B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/21 Warning Letter says the specific violations were: * failing to maintain the buildings used in the manufacture, processing, packing,
Drugs
FDA has issued Warning Letters to operators of two Web sites that the agency says “illegally market potentially dangerous unapproved and misbranded opioid medications, including tramadol.” The letters tell the companies to immediately stop offering violative drugs for sale to U.S. consumers. The two Web sites are azmedicinalshop.com
Drugs
A 9/24-9/28/18 FDA inspection at Dong Yuan Technology Co., Shandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/18 Warning Letter says specific violations were: * failing to establish and follow laboratory controls that include scientifically sound and
Drugs
A New York federal judge has denied a Novartis motion for summary judgment in a whistleblower case alleging a decade-long company-wide kickback scheme through which the company paid doctors honoraria and other forms of remuneration for taking part in purportedly educational promotional programs to induce doctors to prescribe
Drugs
FDA has issued Evoke Pharma a complete response letter on its 505(b)(2) NDA for Gimoti (metoclopramide) nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The letter cites fewer issues than a company-received multidisciplinary review letter, Evoke says. It states that two
Drugs
FDA will hold a 5/13 public hearing to discuss access to affordable insulin products and issues related to development and approval of biosimilars and interchangeable insulin products. A Federal Register notice says the agency wants to hear input from patients, families, healthcare providers, and other stakeholders who live with
Drugs
Fresenius Medical Care has agreed to pay $231 million to resolve investigations by the Department of Justice (DoJ) and the Securities and Exchange Commission into violations of the Foreign Corrupt Practices Act related to its activities in various alleged corrupt schemes to obtain business in multiple foreign countries. According to
Drugs
Legislation introduced by Reps. Diana DeGette (D-CO) and Tom Reed (R-NY), who serve as the co-chairs of the Congressional Diabetes Caucus, would make permanent a new FDA policy that was put in place in December to help speed up the time it takes for biosimilars to get
Drugs
FDA has approved a Merck EMD Serono NDA for Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated syndrome, an agency release says. (XXINSERT LINKXX) The
Drugs
FDA has approved a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressair’s (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that the therapy reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events in
Drugs
The Federal Trade Commission (FTC) has released an opinion and final order against generic company Impax Laboratories, finding that it engaged in an illegal pay-for-delay, or “reverse payment,” settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals’s branded extended-release opioid pain