Drugs
A 4/23-4/27/18 FDA inspection at Hangzhou Zhonbgo Industrial Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 11/27/18 Warning Letter says the specific violations were: * failing to have, for each batch of
Drugs
Pain Therapeutics says that at a 1/31 meeting with FDA to discuss its drug candidate Remoxy ER, it learned that (1) FDA denies making math errors, material mistakes, or misrepresentations during a 6/2018 advisory committee meeting for Remoxy, “despite clear evidence to the contrary”; (2) comparator data is
Drugs
CDER has released its 2018 Drug Trials Snapshot Summary Report, highlighting 59 novel drugs and the extent to which their safety and efficacy data was based on demographic factors. The document says the snapshots posted throughout the year provide information on the diversity of participants in clinical trials and the
Drugs
Sen. Bernie Sanders (I-VT) is asking Catalyst Pharmaceuticals to explain how it set an annual list price of $375,000 for Firdapse, a drug used to treat Lambert-Eaton myasthenic syndrome, a rare neuromuscular disease. Sanders says that for two decades patients received an unapproved version of the same
Drugs
FDA last year approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications, and four biosimilar applications in oncology. “These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and
Drugs
Genus Lifesciences has petitioned FDA to refuse to accept any submissions by Lannett Company for its 505(b)(2) application for cocaine hydrochloride 4% and 10%. A Genus 2/1 petition says the Lannett submissions are barred by the new chemical entity (NCE) exclusivity arising from FDA approval of the
Drugs
FDA says that Lymol Medical missed a milestone final report due date in the timetable for completion of a postmarketing requirement for sterile talc powder under its NDA. A 1/8 Warning Letter says the failure to comply without demonstrating a good cause for noncompliance violates the law and misbrands
Drugs
FDA has issued Alkermes a complete response letter on its NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder. The agency letter requests additional clinical data to provide substantial evidence of the therapy’s effectiveness, according to the company. Alkermes says it plans to meet with FDA
Drugs
Generic drugs lobbying arm Association for Accessible Medicines (AAM) says it is concerned that new legislation introduced by Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) may have the “unintended impact of reducing competition in the prescription drug market and thus lead to patients continuing to pay
Drugs
FDA says it is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with Abiomed’s Impella RP System than the rate previously observed in premarket clinical studies. The Impella RP System is a temporary right heart pump system intended to help
Drugs
DRUGS FDA has approved a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-
Biologics
After 16 years at FDA, CDER Therapeutic Biologics and Biosimilars Staff director Leah Christl is leaving to pursue other opportunities, effective 2/22. She joined FDA in 2003 as a regulatory project manager in the Over-the-Counter Drug Products Division. She later served as associate director for regulatory affairs
Drugs
West Pharmaceutical Services has recalled its Vial2Bag fluid transfer system that was manufactured between 3/15/2016 and 1/8/2019 due to the possibility that the device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. If inadequate
Drugs
Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) have introduced legislation aimed at keeping drug prices down by increasing competition in the generic drug market. The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act (HR 938) would aim to prevent the
Drugs
FDA has issued Sunovion Pharmaceuticals a complete response letter on its NDA for apomorphine sublingual film for use in treating “off episodes” (the re-emergence or worsening of symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease. In the letter, FDA requested additional information and analyses,
Drugs
FDA commissioner Scott Gottlieb says the agency will advance additional policies this year to promote generic competition for complex drugs. “Among other things,” he says in a statement, “we intend to issue additional guidance documents for developing specific complex generic drugs, as well as address categories of complex drugs that
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it embraces the collaborative approach FDA has taken towards identifying and mitigating drug shortages, including the open communication that the agency has fostered. In a comment on an agency 11/27/18 public meeting on drug shortages, PhRMA says it and its
Drugs
Federal Register notice: FDA has announced a 3/8 Microbiology Devices Panel meeting to discuss and make recommendations on new or alternative approaches to the clinical study design and evaluation of devices detecting human papillomavirus (HPV) nucleic acid. The approaches will take into consideration scientific data generated since the approval
Drugs
FDA has approved the first generic version of the GlaxoSmithKline Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease. The generic inhaler
Drugs
FDA has released a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. According to FDA, Section 506I imposes additional reporting requirements on NDA and ANDA holders, including: * Notification of withdrawal from sale, which requires NDA and ANDA holders
Drugs
Nature’s Rx has recalled its Silver Bullet 10x product because it was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared ingredients may pose serious health risks because consumers with underlying medical issues may take the
Drugs
FDA has issued a guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products, to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production