Drugs
FDA has given accelerated approval to Array BioPharma’s Braftovi (encorafenib) with cetuximab (Lilly’s Erbitux) and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation as detected by an FDA-approved test. Array is a Pfizer subsidiary. An agency statement says efficacy was evaluated in the
Drugs
FDA says Alcon Laboratories issued a nationwide recall of one lot of its Systane Lubricant Eye Drops Ultra PF Single Vials On-The-Go 25 count, due to fungal contamination. An agency statement says the company evaluated a consumer complaint of foreign material observed inside a single-use vial and
Drugs
FDA has approved Galderma’s Nemluvio (nemolizumab) for a new indication to treat patients aged 12 and older with moderate to severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. In 8/2024, the agency approved
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Bristol Myers Squibb’s Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or carbozantinib (Exelixis’ Cabometyx)
Drugs
FDA has approved Novo Nordisk’s Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients ages 12 and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. An agency statement says Alhemo is
Drugs
FDA has approved a new indication for Lilly’s Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea in adults with obesity when used in combination with a reduced-calorie diet and increased physical activity. An agency statement says the approval for this indication was based on results from
Drugs
FDA says Astellas Pharma has recalled one lot of Prograf 0.5 mg (tacrolimus) and one lot of Astagraf XL 0.5 mg (tacrolimus extended-release capsules) because some bottles shipped to the U.S. may contain empty capsules. The company said transplant patients who consume empty Prograf or Astagraf
Drugs
A 7/22-7/26/2024 FDA inspection at the Bhargava Phytolab Private Limited drug manufacturing facility in Bhiwadi, Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and significant deviations from CGMP for active pharmaceutical ingredients (APIs). A 12/18/2024 Warning Letter
Drugs
FDA has published a Federal Register notice to encourage companies to submit sNDAs to modify the labeling statements for buprenorphine-containing transmucosal products indicated to treat opioid dependence (BTODs). An agency statement (contains a link to the Federal Register notice) says the agency has received feedback from multiple interested parties
Drugs
FDA has approved Neurocrine Bioscience’s Crenessity (crinecerfont) to be used with glucocorticoids to control androgen in adults and pediatric patients aged 4 and older with classic congenital adrenal hyperplasia (CAH). An agency statement says the Crenessity approval was based on two trials in 182 adults and 103 children with
Drugs
FDA says Endo USA has recalled all lots within expiry of its Adrenalin Chloride Solution (EPINEPHrine nasal solution) 30mg/30mL. An agency notice says the product pre-dates the 1938 Federal Food, Drug, and Cosmetic Act and was never submitted for FDA approval. Thus, it is legally considered to be
Drugs
FDA has sent Warning Letters to Xcel Peptides, Swisschems, Summit Research, and Prime Peptides for introducing unapproved semaglutide (Nova Nordisk’s Ozempic and Wegovy), tirzepatide (Lilly’s Zepbound), and/or retatrutide (experimental Lilly drug) products into interstate commerce. The agency said its review of the companies’ Web sites and social
Drugs
FDA has approved Hikma Pharmaceuticals USA’s generic glucagon-like peptide-1 receptor agonist that references Novo Nordisk’s Victoza (liraglutide injection) 18 milligram/3 milliliter. An agency statement says the drug is indicated to improve glycemic control in adults and pediatric patients aged 10 and older with Type 2
Drugs
FDA has approved an expanded indication for Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to include children as young as age 2. A company statement says Imcivree is indicated to reduce excess body weight and Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1)
Drugs
FDA has approved Ionis Pharmaceuticals’ Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). The company says Tryngolza is the first FDA approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides clinically meaningful reduction in acute
Drugs
Axsome Therapeutics says it will submit an NDA for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimer’s disease agitation despite reporting mixed Phase 3 clinical trial data. The investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor has previously been granted
Drugs
Novo Nordisk has petitioned FDA to exclude its liraglutide from the agency’s list of bulk drug substances that may be used by outsourcing facilities in compounding. Liraglutide is a GLP-1 agonist and is the active ingredient in the company’s diabetes drugs Victoza and Xultophy and weight-loss
Drugs
FDA has released a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility. A 6/14-6/26/2024 inspection found multiple violations, including significant GMP issues for finished drugs. Some specific violations were: * failure to establish
Drugs
FDA has approved Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. An agency notice says efficacy was established in Study CK-301-101 in 109 patients. The major outcome measures
Drugs
FDA has approved Xcovery Holding’s Ensacove (ensartinib) for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. An agency statement says efficacy was evaluated in the eXALT3 trial in 290 patients who were randomized
Drugs
FDA says its laboratory analysis of Rhino 11 gummies found the presence of tadalafil (Lilly’s Cialis) that is not listed on the product label. An agency notice says the product is promoted and sold for sexual enhancement on various Web sites and possibly in some retail stores. The notice
Drugs
A 4/11-4/18/2024 FDA inspection at the Micro Orgo Chem drug manufacturing facility in Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 12/3/2024 Warning Letter says the specific violations were: * failure to adequately validate written