Drugs
FDA has approved a Noven Pharmaceuticals NDA for Secuado (asenapine) transdermal system for treating adults with schizophrenia. Approval is based on data from a Phase 3 placebo-controlled study in which Secuado achieved the primary endpoint of statistically significant improvement from baseline compared to placebo at week six, according to
Drugs
With Canada and the European Union releasing much of the data companies submit when seeking approval for a new drug, biologic, or medical device, pressure is being placed on FDA to change its stance that says that such information contains confidential trade secrets and can’t be released. National Public
Drugs
A 4/8-4/16 FDA inspection at Torrent Pharmaceuticals, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/8 Warning Letter says specific violations were: * failing to follow written procedures for production and process control designed to assure that the drug
Drugs
A 4/15-4/20 FDA inspection at Glenmark Pharmaceuticals, Mumbai, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/3 Warning Letter says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
The Association for Accessible Medicines suggests that FDA include additional details concerning expected justification content when referencing an Inactive Ingredient Database (IID) listing that differs from the proposed excipient in nomenclature, molecular weight, viscosity, or grade. The group made the suggestion in its comment to an FDA draft guidance on
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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
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
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-
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
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
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
Drugs
A new study in JAMA suggests there is limited feasibility for the the idea of replicating clinical trials using real-world evidence (RWE). Researchers from numerous academic centers and industry examined clinical trials with human participants that were published in high-impact journals in 2017 and found “only 15% of
Drugs
FDA has cleared a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing. The company says the single-use, sterile, antimicrobial gauze dressings are impregnated with Hexagen, Turn’s petrolatum-based wound care emulsion. Its broad-spectrum antimicrobial provides protection against bacteria, fungi, and yeasts, it says.
Drugs
There are seven inspection observations on the FDA-483 released by the agency following a 9/19-9/27 inspection at the Aurobindo finished drug manufacturing facility in Telangana, India. The observations were: * failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components
Drugs
FDA has released the FDA-483 issued following a 9/16-9/20 inspection at the Lupin API manufacturing facility in Maharashtra, India. The three inspection observations on the form were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed; * batch production and
Drugs
FDA has released a new Biosimilar User Fee Act (BsUFA) performance dashboard on the FDA-Track reporting Web site. An agency notice says the dashboard provides “more user-friendly and transparent information for the BsUFA performance metric goals.” The dashboard provides a concise, interactive, and visual presentation of data in
Drugs
FDA has granted a de novo clearance for OraSure Technologies’s OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola. “The test provides a rapid, presumptive diagnosis that