Drugs
The Government Accountability Office (GAO) says FDA implemented requirements for reviewing applications for sunscreen active ingredients within time frames set by the 2014 Sunscreen Innovation Act. The act contained a provision for GAO to examine FDA’s implementation. As an example of meeting time frames, GAO says FDA issued an
Drugs
FDA has approved Genentech’s Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. An FDA announcement says that Hemlibra is a first-in-class therapy that works by bridging other
Drugs
FDA has approved Pfizer’s Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. “This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with
Drugs
FDA has accepted an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add-on therapy with its Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. The agency has set a 6/30/2018 user fee review target action date for the submission. “If approved, administration of
Drugs
Former CDER Office of Process & Facilities director Robert Iser has joined Parexel as vice president of regulatory consulting services, where he will help clients avoid market delays due to compliance or quality problems. Iser spent more than 15 years at the agency. Most recently, he was responsible for reviewing
Drugs
Public Citizen is petitioning FDA to withdraw from the market all medications containing the angiotensin II receptor blocker (ARB) olmesartan medoxomil (Daiichi Sankyo’s Azor, Benicar, Benicar HCT, and Tribenzor, with all generics of these drugs). The advocacy group petition says that olmesartan medoxomil is associated with a risk of
Drugs
Baxter International has recalled one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection due to the potential presence of particulate matter which may have entered the solution during the manufacturing process, a recall notice says. “The particulate matter was identified by Baxter during a stability study, and
Drugs
A Phase 3 study by Acorda Therapeutics of tozadenant for Parkinson’s disease could be in jeopardy after the company reports five deaths in the study and recommending increased frequency (weekly) of blood cell count monitoring for trial participants. The increased monitoring is in response to cases of agranulocytosis, possibly
Drugs
An FDA drug safety alert says that Takeda’s gout drug Uloric (febuxostat) may have an increased risk of heart-related death when compared to allopurinol (Mylan’s Aloprim and Casper Pharma’s Zyloprim). This is the preliminary finding from an FDA-required safety study conducted by Takeda. “Once the
Drugs
FDA has cleared an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The device is intended to provide clinicians with the option of non-invasive retrograde flushing of the
Drugs
FDA has approved an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and
Drugs
A 3/27-4/7 FDA inspection at the Lupin Limited drug manufacturing facility in Goa, India, and a 5/8-5/19 inspection at the facility in Indore, Madhya, Pradesh, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at each plant, according to an
Drugs
FDA has approved an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. The pill has a sensor embedded in it that records when the medication was taken. It is approved
Drugs
FDA commissioner Scott Gottlieb says the agency has issued a public health advisory related to growing concerns about risks associated with use of a botanical substance known as kratom. In a statement, Gottlieb emphasizes that there are no FDA-approved products containing kratom and that no drug manufacturer has filed
Drugs
Yale University and Johns Hopkins University School of Medicine researchers say FDA’s 2006 Unapproved Drugs Initiative (UDI) intended to strengthen the agency’s regulatory oversight of unapproved marketed drugs has led to significant increases in drug prices after UDI regulatory action or approval. Writing in the Journal of the
Biologics
An FDA 4/3-4/28 inspection of RTI Surgical, Alachua, FL, found multiple violations in the firm’s continuing manufacture of a bone graft product consisting of a scaffold composed of human demineralized bone matrix and cortical cancellous chips or strips, copackaged with a redacted isolated bone marrow, cryopreserved
Drugs
As expected, President Donald Trump has nominated former Eli Lilly executive Alex Azar as the next HHS secretary, replacing former Rep. Tom Price, who resigned after his extensive use of private and military jets at taxpayer expense was documented. Before joining Lilly, Azar was a deputy HHS secretary under former
Drugs
The president and owner of a Florida pharmacy has pleaded guilty for his role in a compounding pharmacy fraud scheme, which impacted private insurance companies, Medicare and TRICARE. Nicholas A. Borgesano Jr. (New Port Richey, FL), the president and owner of A to Z Pharmacy of New Port Richey, pleaded
Drugs
Theravance Biopharma and Mylan NV have submitted an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized bronchodilator for treating chronic obstructive pulmonary disease. The submission is supported by the companies’ Phase 3 program — two replicate pivotal Phase 3 efficacy studies and
Drugs
The American Hospital Association (AHA) has urged FDA to intervene and “expedite the resolution of the worsening shortages of small-volume parenteral solutions that are so fundamental to patient care in hospitals.” In an 11/10 letter to FDA commissioner Scott Gottlieb, AHA said the shortages of widely-used, critical
Drugs
FDA has approved an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen injector, indicated for inducing ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure. The product
Drugs
FDA has approved an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar was previously approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of Bipolar I disorder in adults. Without maintenance treatment, 60 to 71% of schizophrenia