Drugs
FDA has issued a new draft guidance on “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” that proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular adverse outcomes (cardiovascular outcome
Drugs
FDA has accepted for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. “Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis
Drugs
FDA has released a draft guidance (XXINSERT LINKXX) on “Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.” The document discusses local safety assessments for the risk of contact dermatitis (irritant, allergic, and photoallergic) when developing topical drug products. The recommendations were developed based in part on
Drugs
Hikma Pharmaceuticals has extended a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials due to the presence of small visible particulate matter (a gelatinous/oily nature that appears black in some of the recalled lots). In December, Hikma voluntarily recalled the
Drugs
FDA has published a draft guidance, Inclusion of Older Adults in Cancer Clinical Trials, with recommendations regarding the inclusion of older adult patients in clinical trials of drugs to treat cancer. Specifically, the document says it has recommendations for including an adequate representation of older adults in cancer clinical trials
Drugs
Stericycle’s first annual State of the Nation 2020: Product Recall report projects increased regulation by FDA and other government agencies this year. The report combines a look at recall activity in 2019 with projections for the future. The 2019 recall story for drugs, Stericycle says, centered on supply chain
Drugs
FDA has published a guidance, Safety Testing of Drug Metabolites, with recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The document applies to small molecule nonbiologic drug products and does not apply to some cancer therapies. FDA says
Drugs
FDA says it has launched its new PDUFA performance dashboards at FDA-TRACK the agency performance management program. “These dashboards offer a more concise, interactive, and visual presentation of some of the data reported in FDA’s legislatively mandated annual PDUFA report to Congress,” an agency announcement says. The dashboards
Drugs
FDA commissioner Stephen Hahn says the agency is taking additional steps to educate consumers and healthcare providers about cannabidiol (CBD) products and to obtain additional data to help evaluate those products. In a statement released online 3/5, Hahn says the agency recently updated the public on concerns about potential
Drugs
FDA has published a guidance to provide answers to common questions about the agency implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009. Under that act, the document says, an application for a biological product approved under section 505 of the Federal Food, Drug,
Drugs
Valisure, which describes itself as an online pharmacy and analytic laboratory that is accredited by the International Organization for Standardization and registered with FDA and the Drug Enforcement Administration, says it has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific batches of prescription drug products containing metformin,
Drugs
Researchers from academic institutions in the UK and Belgium say their study of 63 of the 355 new therapeutic drugs and biologic agents approved by FDA between 2009 and 2018 shows that the estimated median capitalized research and development cost per product was $985 million, counting expenditures on failed trials.
Drugs
The U.S. government has filed a False Claims Act suit in Massachusetts federal court against Mallinckrodt ARD (previously Questcor Pharmaceuticals) for allegedly underpaying Medicaid rebates caused by large increases in the pricing for its drug H.P. Acthar Gel. The government’s complaint alleges that despite Acthar being first
Drugs
FDA says it is requiring a Boxed Warning for Merck’s Singulair (montelukast sodium) and its generic forms to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug that is indicated to treat asthma and allergic rhinitis. The Boxed Warning will advise healthcare providers to
Drugs
[Analysis by David McFarland] Missteps by federal agencies and the Trump Administration grappling with the coronavirus outbreak will no doubt make a nice “lessons learned“ case study one day on what not to do the next time the U.S. faces a pandemic. Because we at FDA Webview tend to
Drugs
A 5/21-5/28/19 FDA inspection at Market America, Greensboro, NC, found multiple violations in the firm’s distribution of dietary supplements that are contract manufactured for it under the firm’s name. A just-released 2/12 Warning Letter says the company failed to submit a Serious
Drugs
Teva says it is generally pleased with an FDA draft guidance on product development and quality considerations for transdermal and topical delivery systems but believes there are some technical issues that require further clarification. The company’s comment letter raises several line-by-line technical issues for clarification. Mylan says
Drugs
KemPharm has submitted a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder. Serdexmethylphenidate is KemPharm’s prodrug of d-methylphenidate, the company says, adding that it has a 30 minute onset of action, a duration effect of 13 hours, and avoids unnecessary spikes in d-methylphenidate
Drugs
In 3/3 letters to FDA and drug industry associations, Public Citizen says it is important that all drug shortages related to the Covid-19 epidemic be publicly identified. FDA announced the first related medication shortage 2/27, Public Citizen says in a letter to FDA commissioner Stephen Hahn, but
Drugs
Sandoz has agreed to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixing investigation. A four-count felony charge was filed 3/2 in the U.S. District Court for the Eastern District of Pennsylvania, charging Sandoz with participating in four
Drugs
FDA has approved a Biohaven Pharmaceutical Holding NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The quick dissolving product is intended to provide pain relief and return patients to normal function within one hour, the company says. The drug is not indicated for preventing migraines,