Devices
FDA has classified as Class 1 a bioMerieux recall of its Vitek 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards due to false results for some strains of methicillin-resistant Staphylococcus aureus (MRSA). A recall notice says the recall was ordered because of false negative or false susceptible results for
Drugs
FDA has approved a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two years of age and older taking clobazam. Approval was based on data from two multicenter placebo-controlled trials, STICLO France and STICLO Italy. The primary efficacy endpoint in both trials
Devices
FDA has approved Roche’s cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZeneca’s Iressa (gefitinib) in treating non-small cell lung cancer (NSCLC). The cobas test is currently the only FDA-approved diagnostic test for NSCLC using liquid biopsy. Epidermal growth
Drugs
FDA has approved a Kala Pharmaceuticals NDA for Inveltys (loteprednol etabonate ophthalmic suspension) 1% for treating post-operative inflammation and pain following ocular surgery. The drug is the first twice-daily ocular corticosteroid approved for this indication, according to the company. All other ocular steroids are only approved for four-
Biologics
FDA has published a draft guidance, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, to assist sponsors who are developing medical products to treat the underlying pathophysiology and structural progression of osteoarthritis. The document says that approvals for osteoarthritis to date have been based
Drugs
FDA commissioner Scott Gottlieb says the agency has contracted with the National Academies of Sciences, Engineering, and Medicine to help advance development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. “The primary scope of this work is to understand what
Drugs
The 3rd Circuit Court of Appeals upheld a Pennsylvania federal court ruling dismissing a whistleblower suit brought by several states against nine drug companies alleging that they underpaid rebates to the states under the Medicaid Drug Rebate Program. The appeals court decision says the central issue was whether the companies
Drugs
FDA has issued Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding in women with uterine fibroids. The letter requests additional information and cites safety concerns regarding post-marketing reports outside the U.S., according to the company. Allergan plans to meet
FDA Policy/General
Federal Register notice: FDA has announced a 10/19 public meeting entitled “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC).” The meeting is intended to provide stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission
FDA Policy/General
Federal Register notice: FDA has determined that Ditropan XL (oxybutynin chloride) extended release tablets 15mg were not withdrawn from sale for safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the
Devices
FDA has cleared a MagVenture 510(k) for a faster treatment protocol for its Transcranial Magnetic Stimulation and its use in treating depression. The company says the protocol, called Theta Burst Stimulation, will cut treatment time to three minutes per session compared with up to 37 minutes. The FDA clearance
Drugs
FDA has approved Dompe Farmaceutici’s Oxervate (cenegermin), the first drug approved for treating neurotrophic keratitis, a rare corneal disease. An agency statement says the drug’s safety was studied in 151 patients in two eight-week studies. Across both studies, the agency says, complete corneal healing in eight weeks
Drugs
FDA has issued a complete response letter (CRL) for Mallinckrodt’s stannsoporfin, a heme oxygenase inhibitor under investigation for treating newborns with indicators of hemolysis who are at risk of developing severe jaundice. The company says the agency provided guidance about areas of further evaluation for resubmitting the stannsoporfin NDA.
FDA Policy/General
Federal Register notice: FDA has announced a 9/20 public meeting entitled “Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care.” The meeting is intended to generate a discussion with providers and health system stakeholders on medications to treat opioid use
Devices
FDA has cleared a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System. The ultrasound system with a proprietary radiofrequency ablation device “provides a transcervical, incision-free, uterus-preserving treatment for uterine fibroids,” the company says. The device exceeded “FDA-specified 12-month primary endpoint performance
Drugs
A 3/26-3/29 FDA inspection at Hangzhou Karic Commodities Co., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/31 Warning Letter identified specific violations as: * failing to have, for each batch of drug product, appropriate laboratory determination of
Drugs
The National Alliance on Mental Illness (NAMI) says an FDA draft guidance on developing drugs to treat major depressive disorder “is long overdue. It is important for the agency to take steps to improve the drug review process and ensure greater transparency and improvement about the review process…. This guidance
Drugs
Sen. Edward Markey (D-MA) says it’s possible that FDA ignored red flags that may have resulted in inappropriate prescribing of a certain class of immediate release fentanyl products. In a statement, he referenced an analysis of the FDA REMS (Risk Evaluation and Mitigation Strategies) for the class of
Drugs
A 9/4-9/8/17 FDA inspection at Kyowa Hakko Bio Co., Yamaguchi, Japan, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to an 8/10 Warning Letter. Specific deviations cited in the letter were: * failure of the quality unit to exercise
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” The document is intended to assist sponsors of such drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Quality Attribute Considerations for Chewable Tablets.” The document outlines current thinking on the critical quality attributes that should be assessed during the development of such products. To view the notice, click here.
Drugs
To help mitigate an EpiPen shortage, FDA says it is extending by four months the expiration date for specific lots of EpiPen that are expired or close to expiring. An agency notice cites information from Mylan showing the specific lots involved with the original and new expiration dates. “While product