FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Glenmark Pharmaceuticals, Mumbai, India (10/3): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, Glenmark failed to thoroughly investigate multiple complaints
Drugs
FDA has approved an Akorn ANDA for betamethasone dipropionate lotion USP (augmented), 0.05%, a corticosteroid indicated for relieving inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. Sales of the generic lotion are estimated at $10 million annually. The product will be
Devices
A 5/1-5/6 FDA inspection at Denterprise International, Ormond Beach, FL, found Quality System Regulation and other violations in the firm’s work as specification developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. A 10/9 Warning
Drugs
FDA says it does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine (Zantac) medicines at this time. “The agency is conducting further tests to determine the risk to consumers” of the presence of NDMA (N-nitrosodimethylamine) impurities in ranitidine products, an online question-and-
Drugs
Of 59 new molecular entities approved by FDA in 2018, 48 included a table summarizing whether patient experience data (PED) was used during the agency drug review. Some 71% of the 48 approvals reported using PED in the review, with patient-reported outcomes the most significant source of PED. Sanofi
Drugs
FDA has extended the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that seeks to revise the drug’s label based on results from an open-label Phase 3b clinical trial which evaluated repeat administration of Zilretta in patients with osteoarthritis knee pain.
Drugs
A new JAMA study shows minimal effects from FDA’s recent policies to expand approvals for generic drugs at risk for price spikes and shortages. “From July 2016 to December 2018, the total number of generic drug applications approved by the FDA increased slightly, but the proportion of approvals for
Drugs
FDA has denied a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs indicating that “physicians and pharmacists should exercise extreme caution when switching patients who are seizure free or whose seizures are well controlled on a given anti-epileptic drug.” In stating the basis for
FDA Policy/General
A 10/14 New York Times article examines FDA’s and the federal government’s alleged foot-dragging over the last decade that allowed e-cigarette use and marketing to explode to the detriment of teenagers. “In dozens of interviews, federal officials and public health experts described a lost decade
Drugs
FDA has accepted for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders, a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. The company says UX007 is a “highly purified, pharmaceutical-grade, medium-
Devices
FDA has cleared an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory devices designed to support and expand clinical use of its patient-specific cranioplasty implant already cleared by the agency. The new accessories are intended to assist neurosurgeons
Drugs
FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that led to the recall of several common blood pressure medicines known as sartans. Earlier this year, FDA temporarily increased the allowable level of the chemical while it undertook the review. A new analysis
Devices
FDA has cleared a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air. The device, according to the company, features 69 laser diode terminals that generates a laser treatment that is evenly spread on the scalp to activate follicle cell proliferation, increase blood flow,
FDA Policy/General
CDRH Listing on Upcoming Guidance Documents Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019 Info Collection on 510(k) 3rd-party Reviews Federal Register notice: FDA submits
FDA Policy/General
DEVICES FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for
FDA Policy/General
Federal Register notice: FDA has announced its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. In addition, FDA has established a docket where comments are being accepted on prioritizing topics for guidance development. One listing outlines
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “510(k) Third-Party Review Program” (OMB Control Number 0910-0375). The program permits FDA to accredit persons in the private sector to review certain 510(k)s. A third party wishing to participate needs to submit
Drugs
Innoveix Pharmaceuticals has recalled all sterile compounded drug products due to sterility assurance concerns. Affected products are injectable human chorionic gonadotropin and injectable sermorelin with growth hormone-releasing peptide-2, according to a recall notice. Administering a drug product that is not sterile could result in serious infections, which may
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance for Industry on Registering with the Center for Veterinary Medicine’s (CVM) Electronic Submission System — 21 CFR 11.2OMB” (Control Number 0910-0454). CVM has placed notifications in a docket identifying documents acceptable for electronic submission
Drugs
FDA has issued a highly redacted 38-page Form-483 following an inspection at drug manufacturer Cipla in Goa, India, that concluded 9/27. For example, the first 11 pages cited the company over its equipment and utensil cleaning. FDA also cited Cipla for its aseptic processing areas being deficient,
Drugs
FDA has approved Eli Lilly’s Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults. Approval was based on data from two placebo-controlled clinical trials involving almost 3,200 adults with a history of migraines. “In both studies, the percentages of patients whose
Devices
FDA has cleared a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty. The robotic device includes CT-based 3D pre-surgical planning software which “allows the surgeon to design and prepare, in a virtual environment, the patient’s unique knee joint