Drugs
Macleods Pharmaceuticals has recalled one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern. The recall is due to unacceptable amounts of N-nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited. Last month, an updated FDA
Drugs
A new FDA safety alert warns patients and healthcare professionals about Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) after a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of the drug was used in patients with rheumatoid
FDA Policy/General
Draft Guide on Nicotine Replacement Drug Products Federal Register notice: FDA makes available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” 02/22/2019 Rule on Bulk Drug Substances for Compounding Federal Register notice: FDA issues a final rule to establish criteria for
FDA Policy/General
BIOLOGICS FDA has approved a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults
Devices
FDA has released a draft guidance entitled “Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.” The document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices. The scope of this document is limited to
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug etoposide toniribate, described as a novel topoisomerase II inhibitor intended for treating relapsed refractory biliary tract cancer. Also known as cholangiocarcinoma, biliary tract cancer is a rare disease that starts in the bile ducts. It is the
Drugs
FDA has accepted for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies. The submission is supported by data from the PREVENT study in patients with anti-AQP4 auto antibody-
Devices
ICU Medical has begun a Class 1 recall of one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective cap. “In uncommon circumstances a plastic particle could enter the drug delivery system and be infused into a patient's intravenous
Devices
FDA has approved a Biotronik PMA for its Orsiro drug-eluting stent (DES) system. The company says the device is the first DES to outperform the clinical standard, Abbott’s Xience. Orsiro is indicated for use in percutaneous coronary intervention procedures. The cobalt chromium metal stent elutes sirolimus via BIOlute,
Drugs
FDA commissioner Scott Gottlieb and CDER director Janet Woodcock are defending the agency’s oversight of the generic drug industry to quash any doubt that generics are of lesser quality than branded drugs. In a 2/22 statement, the FDA leaders take exception to recent media reports suggesting FDA has
Drugs
An FDA drug safety review has concluded that an increased risk of death exists with Takeda’s Uloric (febuxostat) compared to another gout medicine, allopurinol. The conclusion is based on results from a safety clinical trial that found an increased risk of heart-related death and death from all causes
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support nicotine replacement drug products for smoking cessation and related chronic indications. It focuses on
Drugs
FDA has approved changes to the prescribing information for Pfizer’s Chantix (varenicline) that specifies that the drug is not recommended for pediatric patients 16 years of age or younger because its efficacy in this population has not been demonstrated. Chantix is a nicotinic receptor partial agonist indicated for use
Devices
A 3/19-4/13/18 FFDA inspection at American Preclinical Services, Minneapolis, MN, found violations of Good Laboratory Practice regulations in the company’s participation in several nonclinical laboratory studies. A 2/12 Warning Letter corrects a Warning Letter issued 10/4/18. Inspection observations listed on an FDA-
Devices
FDA has cleared an Intuitive Surgical 510(k) for the Ion endoluminal system to enable minimally invasive biopsies in the peripheral lung. The device uses an ultra-thin articulating robotic catheter that can move 180 degrees in all directions. “The outer diameter of the catheter is 3.5 mm, which
Drugs
FDA has released a draft guidance on “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support NRT drug products for smoking cessation and related chronic indications. It focuses on drug development and trial
Devices
FDA has cleared an Axilum Robotics 510(k) for the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the MagVenture Transcranial Magnetic Stimulation (TMS) Therapy system treatment coil. The device is based on the company’s new platform that uses a proprietary optical tracking system, which
Drugs
FDA has issued a proposed rule to update regulatory requirements for most sunscreen products in the U.S. The proposed rule is intended to bring nonprescription, over-the-counter sunscreens that are marketed without agency approved applications up to date with the latest science to better ensure that consumers have
Drugs
The Justice Department says four companies and three individuals have agreed to plead guilty to federal criminal charges related to illegally importing and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs falsely marketed as herbal remedies for men. A department news release also says two new cases were
Devices
FDA has issued a guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), to help describe the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. The document says that focusing the agency’s
Devices
FDA has issued a guidance, Refuse to Accept Policy for 510(k)s, to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. “Focusing FDA’s review resources on complete
Devices
FDA is reminding stakeholders that 2/21 is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices. The agency says the change will require that data submitted from clinical investigations outside the U.S. to support an