Drugs
FDA has approved two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs — Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg); and Pifeltro (doravirine) 100 mg, a new non-nucleoside reverse transcriptase inhibitor to be administered in
Drugs
A bipartisan group of three House members have introduced H.R. 6688 to establish the Prescription Safety Alert System for covered drug products. The legislation, introduced by Reps. Tom Macarthur (R-NJ), Ann Kuster (D-NH), and Barbara Comstock (R-VA), is known as the Analyzing and Leveraging Existing Rx
Drugs
FDA has accepted an Ultragenyx Pharmaceutical proposal to submit an NDA for UX007 for treating long-chain fatty acid oxidation disorders based on existing data. A pre-NDA meeting is being scheduled for later this year to iron out the submission details, the company says. Data submitted to FDA for
Drugs
FDA commissioner Scott Gottlieb says the agency plans to withdraw its 2014 analgesic guidance document on developing new pain drugs and replace with at least four new guidances to create a more efficient path for new product innovation. In a statement updating progress against the opioid epidemic, Gottlieb says the
Drugs
Accord Healthcare has recalled one lot of hydrochlorothiazide tablets USP, 12.5 mg, due to a product labeling mix up. A 100 count bottle of hydrochlorothiazide tablets was found to contain 100 spironolactone tablets USP 25 mg. Hydrochlorothiazide tablets are indicated for managing hypertension. Spironolactone tablets are indicated in managing
Drugs
FDA has accepted for review an Ortho Dermatologics NDA resubmission for Duobrii (halobetasol propionate and tazarotene) lotion, indicated for treating plaque psoriasis. In June, FDA issued a complete response letter, rejecting the NDA over questions regarding pharmacokinetic data, according to the company. The agency has accepted the filing as Class
Drugs
As required under PDUFA 6, FDA is implementing a pilot meeting program that affords drug sponsors who are selected the opportunity to meet with agency staff to discuss using complex innovative trial design (CID) approaches in medical product development. An 8/30 Federal Register notice says the pilot will run
Drugs
An FDA drug safety alert warns that cases of a rare and serious infection of the genital area have been reported with sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are indicated for Type 2 diabetes. The agency says it is requiring a new warning on all SGLT2 inhibitors and to
Drugs
Ionis Pharmaceuticals and its affiliate Akcea Therapeutics have received an FDA complete response letter rejecting an NDA for Waylivra (volanesorsen), indicated for treating familial chylomicronemia syndrome (FCS). The ultra-rare, hereditary disease causes unpredictable and potentially fatal acute pancreatitis, chronic complications due to permanent organ damage, and a severe impact
Drugs
CDER has promoted Office of Strategic Programs (OSP) deputy director Mary Ann Slack to permanent director. OSP oversees many of the Center’s strategic initiatives and modernization efforts, including development of benefit-risk and other decision support tools, data standardization, program analysis, business informatics, and user fee negotiations. Slack has
Drugs
FDA says it has warned four more online networks with a total of 21 Web sites to stop marketing potentially dangerous, unapproved, and misbranded versions of opioids, including tramadol (Ultram). Commissioner Scott Gottlieb says in a statement that the Warning Letters sent by FDA this summer now total 13, covering
Drugs
Keryx Biopharmaceuticals is asking FDA to recognize regulatory exclusivity for its Auryxia (ferric citrate) oral tablets containing “a novel mixture of covalent metal-ion complexes as its active moiety.” The company’s petition says that although the agency approved Auryxia nearly four years ago, it still has not made a
Drugs
Branded drug companies are cautiously supportive of a bullet point in the Trump Administration’s new trade understanding with Mexico that would extend drug patent exclusivity for 10 years and would expand the scope of products eligible for protection. However, generic drug manufacturers say the move would delay biosimilar competition.
Drugs
Public Citizen says the CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial) being conducted by the National Institutes of Health “is deeply flawed, riddled with serious regulatory and ethical lapses, and must be stopped.” In the experiment, a Public Citizen statement says, seriously ill sepsis patients are given
Drugs
The 1st Circuit Court of Appeals has ruled that a federal district court properly dismissed a suit alleging that state laws can require manufacturers of prescription eye drops to redesign their bottles so that they dispense a smaller drop. Both courts ruled that such a packaging change would require FDA
Drugs
FDA has granted Reflection Biotechnologies an orphan drug designation for RBIO-101, an adeno-associated virus gene therapy product for treating Bietti's Crystalline Dystrophy (BCD), a rare retinal degeneration. “In BCD, progressive atrophy and degeneration of the retinal pigment epithelium (RPE) lead to symptoms similar to those of
Drugs
FDA is proposing to ban three bulk drug substances — bumetanide, nicardipine hydrochloride, and vasopressin — from its list of bulk drug substances (active pharmaceutical ingredients) that outsourcing facilities may use in compounding. This is the first time that FDA has issued a proposal regarding whether to include bulk drug substances to
Drugs
Public Citizen says that an FDA draft guidance on assessment of drugs’ pressor effects “is vague and will thereby fail to effectively identify the cardiovascular risk of drugs that have hypertensive effects.” The advocacy group’s comment letter lists several limitations of the draft and recommends several revisions. Roche/Genentech
Drugs
FDA has approved a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema (HAE) attacks in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent swelling attacks in various parts of the body. The company
Drugs
FDA has approved Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) in combination with Genentech’s rituximab for treating Waldenström's macroglobulinemia (WM), a rare blood cancer. Imbruvica first received FDA approval in WM as monotherapy in 1/2015 under the breakthrough therapy designation pathway. This is the ninth FDA approval
Drugs
Pharmaceutical Quality Site Visit Program Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. 08/24/2018 Plasma Lyte Not Withdrawn Due to Safety/Efficacy Federal Register notice: FDA determines that Plasma – Lyte M And Dextrose 5% and
Drugs
The U.S. Court of Appeals for the Seventh Circuit has reversed a lower court decision and $3 million verdict in a product liability case that attempted to hold GlaxoSmithKline (GSK) responsible for injuries caused by a drug, paroxetine, it neither manufactured nor sold. The appeals court decision held that