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
Biologics
FDA has accepted for review an Evolus BLA resubmission for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The agency considered the resubmission a Class 2 response and has set a
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
FDA Policy/General
Washington Legal Foundation litigation division senior counsel Cory Andrews says the notion of including list prices in drug direct-to-consumer ads could not survive a First Amendment challenge and is outside of FDA’s regulatory authority. Writing in a Forbes online column, Andrews challenges the proposal that was raised
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
Devices
FDA has released an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week (see story). The letter notes that the inspection, which was a follow-up to a 2016 inspection at the firm’s Warsaw, IN device manufacturing facility, “revealed continuing, significant violations of the quality system
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
Devices
FDA has cleared a Ceterix Orthopedics 510(k) for an added feature to the NovoStitch Pro Meniscal Repair System — a size 0 suture cartridge. The NovoStitch Pro system enables surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address meniscal tears which have not been amenable to
Biologics
Haemonetics has recalled 10 lots of their Leukotrap RC System with RC2D Filter, intended for collecting whole blood and preparation of red blood cells and plasma or red blood cells, plasma, and platelets with pre-storage leukocyte reduction of red blood cells. Haemonetics has received reports of higher than expected
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a professional sell sheet for Ascend Therapeutics’ EstroGel 0.06% (estradiol gel) makes false or misleading claims and/or representations about the drug’s efficacy. An 8/16 Notice of Violation says the sell sheet “is concerning because it falsely suggests
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
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Kelley-Ross Compounding Seattle, WA (7/30): FDA inspected the firm 7/2017 and cited it for serious deficiencies in its practices
FDA Policy/General
Federal Register notice: FDA has determined that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy its tropical disease definition and added them to the list of designated tropical diseases whose product applications may result in priority review voucher awards. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher. To view the notice, click here.
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