WEDNESDAY, Feb. 19, 2020 -- The U.S. Food and Drug Administration approved three drugs for nonprescription, over-the-counter use -- Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent), Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1 percent), and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2 percent) -- the agency announced Friday.
All three products will now be marketed as nonprescription drugs and will no longer be available as prescription drugs. For the drugs to switch to nonprescription status, data had to demonstrate the drugs' safety and efficacy for self-medication use as directed in proposed labeling, according to the FDA.
MONDAY, Feb. 3, 2020 -- The U.S. Food and Drug Administration approved Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) to alleviate allergic reactions to accidental peanut exposure, the agency announced late Friday.
Palforzia, a powder manufactured from peanuts, is indicated for initiation in individuals aged 4 to 17 years old with a confirmed peanut allergy. Treatment may be continued in individuals aged 4 years and older. "When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy," Peter Marks, M.D., Ph.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.
FRIDAY, Jan. 24, 2020 -- Tazverik (tazemetostat) has received the first approval for treatment of adults and pediatric patients 16 years and older with metastatic or locally advanced epithelioid sarcoma that cannot be resected, the U.S. Food and Drug Administration announced Friday.
The drug works by blocking activity of the EZH2 methyltransferase to help keep the cancer cells from growing. Last month, the Oncologic Drugs Advisory Committee voted unanimously that the benefits of Tazverik outweigh the risks for patients with epithelioid sarcoma, which accounts for less than 1 percent of all soft tissue sarcomas, Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in an agency news release.
FRIDAY, Jan. 10, 2020 -- The kinase inhibitor Ayvakit (avapritinib) has been approved to treat adults with unresectable or metastatic gastrointestinal stromal tumors (GISTs) with a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, the U.S. Food and Drug Administration announced Thursday.
The approval includes GISTs harboring a PDGFRA D842V mutation, the most common exon 18 mutation, and marks the first time a drug is specifically approved for GISTs harboring the PDGFRA exon 18 mutation, which is involved in about 10 percent of GIST cases.
MONDAY, Dec. 23, 2019 -- Enhertu (fam-trastuzumab deruxtecan-nxki) has received accelerated approval for treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the U.S. Food and Drug Administration announced Friday.
Enhertu, a HER2-directed antibody and topoisomerase inhibitor conjugate, is indicated for adults with unresectable or metastatic HER2-positive breast cancer who have received at least two previous anti-HER2-based regimens in the metastatic setting. The recommended dosage of Enhertu is an intravenous infusion of 5.4 mg/kg once every three weeks (21-day cycle) until disease progression or unacceptable toxicity.
THURSDAY, Dec. 19, 2019 -- Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval for the treatment of locally advanced or metastatic urothelial cancer, the U.S. Food and Drug Administration announced yesterday.
Padcev is indicated for adults whose disease has progressed while receiving standard treatment with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-based therapy.
THURSDAY, Dec. 19, 2019 -- The U.S. Food and Drug Administration recently approved marketing of an interoperable automated glycemic controller device, the Tandem Diabetes Care Control-IQ Technology, the agency announced last week.
The device automatically adjusts insulin delivery through connection to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). According to the FDA, this controller is the first that can be used with other diabetes devices that are meant to be integrated into a diabetes management system for automated insulin delivery. With this marketing authorization, the FDA notes iCGMs and ACE pumps can be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. Patients with type 1 diabetes can use the Control-IQ Technology controller with compatible iCGMs and ACE pumps to automatically increase, decrease, and suspend delivery of basal insulin based on insulin delivery history, iCGM readings, and predicted glucose values. The controller can also automatically deliver insulin when the glucose value is predicted to exceed a predefined number.
TUESDAY, Nov. 26, 2019 -- Oxbryta (voxelotor) has been granted accelerated approval for the treatment of sickle cell disease in patients ages 12 years and older, the U.S. Food and Drug Administration announced Monday.
Oxbryta is the first approved treatment for sickle cell disease that directly inhibits the root cause of the disease, sickle hemoglobin polymerization, according to a company press release. Nonclinical studies of Oxbryta have shown the drug inhibits red blood cell sickling and improves red blood cell deformability and the ability of blood to flow. The recommended dosage of Oxbryta is 1,500 mg orally once daily with or without food. For severe hepatic impairment, the recommended dosage is 1,000 mg orally once daily.
TUESDAY, Nov. 26, 2019 -- The U.S. Food and Drug Administration has approved the first tympanostomy tube delivery system that can be performed under local anesthesia in a physician's office, the agency announced Monday.
The Tubes Under Local Anesthesia (Tula) System is indicated for inserting tympanostomy tubes for the treatment of otitis media in adults and children ages 6 months and older. The system includes the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and devices needed for delivery of the ear tubes and the anesthetic into the ear drum. The Tula System uses a small electrical current to deliver the local anesthetic into the ear drum before tube insertion.
MONDAY, Nov. 25, 2019 -- XCOPRI (cenobamate) has received approval for the treatment of partial-onset seizures in adults, the U.S. Food and Drug Administration announced last week.
Following a titration period, the recommended maintenance dose of XCOPRI is 200 mg by mouth daily, but some patients may need an additional titration to the maximum recommended dose of 400 mg daily based on their individual clinical response and tolerance, the FDA noted.