Drugs
FDA has approved an Aquestive Therapeutics NDA for Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. According to the company, Sympazan is the first oral film FDA-approved to treat seizures associated with LGS.
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted 21 to 2 that the benefit-risk profile was not adequate to support approval of an Alkermes NDA for a combination product containing buprenorphine and samidorphan intended to be used as an
Drugs
FDA has approved an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain in adult patients in medically supervised settings. In 10/2017, the agency issued a complete response letter on the original submission, asking for additional safety-related data from
Drugs
FDA has issued a draft guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs and biologics to treat chronic hepatitis B viral infection from IND through NDA/BLA and postmarketing. The document says it will be the focus for continued
Drugs
FDA says healthcare providers and patients should be aware that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the agency and may not have the scientific or clinical evidence to support such use for most medications. An agency safety
Drugs
Heron Therapeutics has submitted an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for managing postoperative pain. The therapy was previously granted both Breakthrough Therapy and Fast Track designations. The submission is based
FDA Policy/General
FDA has told the House Energy and Commerce Committee that the number of Office of Criminal Investigations (OCI) special agents assigned to Port of Entry (POE) duty doubled in August from six to 12. In addition, OCI added an import senior operations manager to oversee the program, and also added
Drugs
The DC Circuit Court of Appeals has ruled that FDA acted properly in denying a request for a hearing and withdrawing an ANDA submitted by Breckenridge Pharmaceutical and Nexgen Pharma for a generic version of Braintree Laboratories’ prescription MiraLax. The court opinion noted that after FDA approved Braintree’s NDA
Drugs
Former FDA associate commissioner Peter Pitts says the agency’s efforts to streamline drug approvals where safety reviews have shown positive results are starting to pay off. Writing in an online column in The Virginia Gazette, Pitts notes that in 2017 FDA approved more than 1,000 generic drugs, 200
Drugs
FDA says that SciGen is recalling specific lots of its hypertension medicine irbesartan for a potential cancer risk due to contamination. The agency says that the recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label. A CNN story also discusses the recent recall of some drugs containing
Drugs
FDA has approved Merck’s Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. Approval was based on data from the KEYNOTE-407 trial, which showed that Keytruda’s combination use with chemotherapy
Drugs
FDA staff in the Office of Generic Drugs and Office of Biostatistics say their review of data collected in the third and fourth calendar years of GDUFA 1 shows a trend toward increased first-cycle approval of ANDAs. Writing in Therapeutic Innovation & Regulatory Science, the FDAers say the rate
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meet 11/1 to consider issues involved in the CDER review of an Alkermes NDA for a combination product containing buprenorphine and samidorphan intended to be used as an adjunct to established antidepressant pharmacotherapy
Drugs
FDA has alerted health care professionals and patients about two-month expiry date extensions on some epinephrine auto-injectors, .15 mg and 0.30 mg, distributed by Impax Generics. The extensions were granted due to intermittent supply interruptions involving the products. “To help ensure patient safety, these products should have
Drugs
Three medical school professors have petitioned FDA to require addition of Warnings, Precautions, a Boxed Warning, and other language to the labeling for all isotretinoin products to inform users of sexual side effects. The 10/26 petition asks for the immediate revision of all isotretinoin labels to: * add Warnings, Precautions,
Drugs
Abbott Laboratories and its spin-off AbbVie have agreed to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promotion efforts to induce physicians to prescribe cholesterol drug TriCor (fenofibrate tablets). According to the Justice Department, between 2006 and 2008 Abbott knowingly paid kickbacks
Drugs
FDA inspected a Minnesota medical center and found violations that “subjected unwitting patients to dangerous and unethical human testing,” according to documents obtained by Public Citizen under the Freedom of Information Act (FOIA). Researchers at Hennepin County Medical Center “failed to obtain consent from test subjects for high-risk clinical
Drugs
FDA has approved a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an indication to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy ages seven and older. Approval was based on data from the multisite Phase 2/3 EXPRESS study, which
Drugs
New research published in the 10/25 online PLOS One journal and supported by CDRH’s Division of Biostatistics outlines an approach that could lead to more patient-reported outcome measures (PROM) being included in drug and device labeling. The researchers say the “PROM has to be valid, reliable and
Drugs
Shire has filed a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin 25% [albumin (human)], which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. Shire received FDA approval for the Georgia facility to manufacture
Drugs
FDA has accepted for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The agency has set a user fee review action target of 2/24/2019.
Drugs
An FDA Advisory Committee has delivered a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all new diabetes drugs. In delivering the mixed vote, the majority of panel members recommended that modifications are necessary to the requirements for conducting such trials, for example allowing