Drugs
FDA has accepted for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections. The user fee review action target date was set for 8/28. The submission includes data from the IGNITE1 and IGNITE 4 Phase 3 clinical trials and showed that twice-daily eravacycline was
Drugs
Synergy Pharmaceuticals is petitioning FDA to require changes to the approved package insert for Forest Laboratories’ Linzess (linaclotide) to ensure that it contains adequate information for its use because it “misrepresents or obfuscates the incidence of adverse events in its clinical trials in several respects.” The petition says a Forest
Drugs
FDA commissioner Scott Gottlieb says the agency is taking new steps to support and expedite development of rare disease products. Writing in an FDA Voice blog post to mark 2/28 as the 11th Rare Disease Day, Gottlieb identifies the actions as: * a new pilot for more efficient orphan designation
Drugs
FDA has approved Eli Lilly’s Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for treating postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. This is the third indication for Verzenio within five months;
FDA Policy/General
Federal Register notice: FDA has announced a 3/27 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a U.S. WorldMeds NDA for lofexidine hydrochloride, indicated for mitigating symptoms associated with opioid withdrawal and facilitating completion of opioid discontinuation treatment. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 3/20 public meeting entitled “Promoting the Use of Complex Innovative Designs in Clinical Trials.” The meeting is intended to seek input on the agency’s development of a guidance document that is required by the 21st Century Cures Act and the FDA
Drugs
FDA says Hospira is recalling three lots of labetalol hydrochloride injection 100 mg/20 mL vial and one lot of labetalol hydrochloride injection to the hospital/institution level due to discovery of cracks on the rim surface of vials for the lots, which is covered by the stopper and crimp
FDA Policy/General
Federal Register notice: CDER has announced a 4/3 public workshop entitled “CDER and You: Keys to Effective Engagement.” The workshop is intended to build on previous efforts to help stakeholders understand how they can engage with the Center to enhance drug development and safety. To view the notice, click
Devices
Medtronic has begun a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defect in the manufacturing process. The devices are intended to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Affected devices
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Q11 Development and Manufacture of Drug Substances — Questions and Answers (Chemical Entities and Biotechnological/Biological Entities).” The document, which was prepared under the direction of the International Council for Harmonization (ICH), includes questions and answers that were developed to clarify
Devices
FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology have announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing protocols to help reduce the risk of infection and increase the safety of the medical devices. The protocols are an update to an interim
Drugs
FDA is expected to release soon two new draft guidances intended to advance medication-assisted treatment (MAT) for opioid addiction. Speaking at the 2/24 National Governors Association annual meeting in Washington, DC, HHS secretary Alex Azar said one guidance will encourage more flexible and creative MAT study designs. “As
Biologics
FDA commissioner Scott Gottlieb says the agency is investigating why this year’s flu vaccine was not very effective against one strain — H3N2. “We’re taking steps to investigate each of [the] potential causes, rule out possible reasons for the variation in effectiveness and improve vaccine efficacy against H3N2,” he
FDA Policy/General
24 ANDA Approvals Withdrawn Federal Register notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed. 02/23/2018 Regulatory Review Period Determined for Zydelig Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.
FDA Policy/General
Federal Regiser notice: FDA has withdrawn approval of 24 ANDAs from multiple applicants. The holders of the applications notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
FDA has released the FDA-483 issued following a 10/16-10/27/17 inspection at a Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations were: * failing to thoroughly review any unexplained discrepancy whether the batch has been already distributed; * employees engaged in the manufacture and
Drugs
Avalere Health says the FDA 1/2017 draft guidance on interchangeability for biologics is “cautious and demanding,” and meeting it would be so costly that it would be difficult for biosimilar manufacturers to achieve a return on their investment. It says the White House Council of Economic Advisors in a
Drugs
The just-released FDA-483 issued following a 1/13-1/20/17 inspection at the Bayer Pharma facility in Leverkusen, Germany, that produces parenteral, solid oral dosage, and active pharmaceutical ingredient drugs contains 11 inspection observations. Specific violations were: * failing to ensure appropriate environmental conditions for filling parenteral products;
Drugs
The FDA-483 issued following a 1/15-1/19 FDA inspection at Indoco Remedies, Goa, India, lists eight inspection observations: * laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards and electronic records do not meet
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.'s Zydelig (idelalisib) is 2,247 days. Of this time, 2,017 days occurred during the testing phase and 230 days during the approval phase. Zydelig is indicated for treating patients
Drugs
FDA has published a guidance, Q11 Development and Manufacture of Drub Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers, to give additional clarification and to promote convergence and improve harmonization of the consideration for the selection and justification of starting materials and of the information that should be
Drugs
FDA has approved a KemPharm NDA for Apadaz (benzhydrocodone, and acetaminophen) for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The U.S. Drug Enforcement Administration has indicated that it will schedule