Drugs
FDA has issued Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult males for conditions associated with hypogonadism. The letter said Lipocine’s drug efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations (Cmax)
Drugs
Start-up pharmacy Valisure (New Haven, CT) has made a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for consumers. The pharmacy's laboratory analysis is behind the ongoing recall of ranitidine, (see earlier story) and it has detected dozens of other quality
Drugs
Regenxbio has filed a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases. The complaint alleges that FDA’s final agency action is “contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations,
Drugs
FDA has granted Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam) for treating complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. ATM-AVI has shown activity against metallo beta-lactamase-producing Gram-
Drugs
FDA Withdraws Haemonetics ANDA Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags. 11/08/2019 Info Collection on Generic Drug Correspondence Federal Register notice: FDA submits to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic
Drugs
Aurobindo is recalling 38 lots of over-the-counter ranitidine tablets (150 mg), Rx ranitidine capsules (150 mg and 300 mg), and ranitidine syrup (15mg/mL). An FDA notice says the medications contain unacceptable levels of N-nitrosodimethylamine (NDMA). The notice says FDA has advised companies to recall their ranitidine
Drugs
FDA has approved Celgene’s Reblozyl (luspatercept-aamt), the first therapy to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. An agency notice says that beta thalassemia (Cooley’s anemia) is an inherited blood disorder that reduces the production of hemoglobin. In people
Drugs
FDA has accepted for review a Cassiopea NDA for clascoterone cream 1% for treating acne. The agency has set a user fee review action target of 8/27. Clascoterone is a new chemical entity and first-in-class topical androgen receptor inhibitor, which is also under development for treating under
Drugs
AbbVie has submitted a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of patients 70 years old or younger with chronic lymphocytic leukemia or small lymphocytic lymphoma. The submission is based on data from the Phase 3 E1912 study, which was sponsored by the
Drugs
Responding to a 4/5 Braeburn petition, FDA says it is revoking, as improperly granted, Indivior’s orphan drug designation for Sublocade (buprenorphine) for treating opiate addiction in opiate users. The agency’s response to Braeburn says the orphan drug designation was predicated on a demonstration that there was “no
Drugs
FDA says it has approved changes to the labeling for Bristol-Myers Squibb’s Baraclude (entecavir) tablet and oral solution to include data from a post-marketing study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients
Drugs
FDA has granted EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies (DLB). The company is planning a Phase 2 proof-of-concept study (AscenD-LB) of neflamapimod in mild-to-moderate DLB. The primary objective is to determine whether neflamapimod can improve
Drugs
Sen. Gary Peters (D-MI) says he is investigating the rising costs of prescription drugs and the short supply of critical medications affecting hospitals and patients. According to Peters’ statement, unaffordable prescription and hospital-administered drugs and the increasing number and length of drug shortages “have become an economic, national
Drugs
A 9/24-9/25 tripartite meeting between FDA, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency discussed further alignment on clinical trial designs for key indications for antibacterial drugs for which convergence has not yet been reached. A statement indicates that the agencies agreed that
Drugs
An FDA October inspection at two Aurobindo Pharmaceutical drug manufacturing facilities in Hyderabad, India, raised concerns about contamination of equipment. The News Minute, an online India news source, reports that the U.S. agency “raised concerns over the lack of hygiene and cleanliness at these facilities.” The online post says
Drugs
Unlearn.AI founder and CEO Charles Fisher, whose company uses artificial intelligence (AI) to streamline clinical trials and make them more efficient, says FDA should be moving to set standards for using AI in drug development. Writing in a Stat online post, Fisher says that AI “can improve efficiency and
Drugs
FDA has cleared a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hysteroscopy System. The device features high-definition optical clarity through its wide-angle lens, long depth of view and a proprietary Smart Focus Algorithm that auto-adjusts focus
Drugs
Public Citizen is petitioning FDA and the Drug Enforcement Administration to initiate proceedings to reschedule 2-[(dimethylamino)methyl]-I-(3-methoxyphenol)cyclohexanol, its salts, its optical and geometric isomers, and salts of these isomers, including Tramadol, from Schedule 4 to Schedule 2 of the Controlled Substances Act. The petition says
Drugs
CBER has issued a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings between individuals in the Center and industry representatives, including sponsors/applicants of user fee related products, and/or individual sponsor-investigators to address issues relating to product development. The document applies to meetings for INDs,
Drugs
GlaxoSmithKline is asking FDA to review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and determine whether there should be any labeling changes. “GSK understands that FDA may be reviewing or will soon review, together with Zofran’s current NDA holder, Novartis, Zofran’s safety profile
Drugs
CDER says the phased implementation of the reorganization of the Office of New Drugs is well underway, with Phase 2 implementation having started 11/4. A notice says Phase 2 will occur over several weeks and involve selecting leadership for several new divisions, including directors for the Divisions of Pharm/
Drugs
FDA has released the FDA-483 with seven observations issued following an 8/27-9/11 inspection at Innoveix Pharmaceuticals, an Addison, TX, producer of sterile and non-sterile drug products. The inspection observations were: * unprotected product intended to be sterile was exposed to lower than ISO 5 classified aseptic