Drugs
Advanced Accelerator Applications has resubmitted an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors in adults. The re-filing follows a 12/2016 complete response letter that cited issues with the format, traceability, uniformity,
Drugs
A Tennessee federal judge has entered a consent decree of permanent injunction against Crown Laboratories and its CEO to stop the distribution of unapproved and misbranded drugs. The Justice Department says the products include urea creams and lotions intended to treat a variety of skin ailments. In a complaint sought
Drugs
AstraZeneca and Merck say they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. A joint announcement says that Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase inhibitor currently approved for BRCA-mutated ovarian
Drugs
Aradigm has submitted an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. The submission is based on data from the Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and confirmatory evidence from the Phase 3
Drugs
Federal Register notice: FDA has classified the assayed quality control material for clinical microbiology assays into Class 2 (special controls). The classification decision is based on a 2015 request from Bio-Rad Laboratories for classification of the Amplichek II device. To view this notice, click here.
Drugs
Hi-Tech Pharmaceuticals is asking the 11th Circuit Court of Appeals to reverse a lower court decision that DMAA (1,3-dimethylamylamine) does not qualify as a dietary ingredient. “Hi-Tech believes that the court’s failure to find that DMAA is a constituent of a botanical, which would have
Drugs
Reacting to significant adverse votes from members of two FDA advisory panels against its Rexista abuse-deterrent oxycodone formulation, executives of Canada’s Intellipharmaceutics say they will try to remedy the concerns raised by the panel members by completing human abuse potential studies in relation to the intranasal and oral
Drugs
Federal Register notice: FDA has announced a new organizational structure for the Office of the Medical Products and Tobacco to establish the Oncology Center of Excellence (OCE) that is intended to optimize an integrated cross-Center regulatory approach and enhance the coordination of medical product development in oncology. The OCE
Drugs
FDA medical reviewers say that Dynavax’ hepatitis B vaccine Heplisav-B (hepatitis B vaccine recombinant and 1018 ISS adjuvant) is effective, but still has potential safety issues. The reviewers’ assessment is in a briefing document released in advance of a 7/28 Vaccines and Related Biological Products Advisory Committee meeting
Drugs
Hyman, Phelps & McNamara says that labeling for Synergy Pharmaceuticals’ Trulance (plecanatide), approved 1/19 to treat chronic idiopathis constipation in adults, fails to contain sufficient side effect information regarding diarrhea. In a citizen petition to FDA, the Washington-based law firm asks that Synergy be required to add additional
Drugs
The Justice Department says that Jason May, the pharmacist in charge of a Hattiesburg, MS, compounding pharmacy, has pleaded guilty to healthcare fraud charges for his role in a scheme that defrauded TRICARE and private insurance companies out of at least $192 million in payments for medically unnecessary compounded medications.
Drugs
FDA has approved a new Boxed Warning on canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) based on recent safety data (see earlier story) that indicate it causes an increased risk of leg and foot amputations. A recent drug safety communication recommends that patients taking the
Drugs
Mylan says that a Mayne Pharma petition asking the agency to refuse to receive and not approve any ANDA referencing its Doryx MPC (doxycycline hyclate delayed-release tablets) unless specific in vitro dissolution criteria are met “appears to be nothing more than a veiled attempt to delay generic competition by
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on the role of the Office of Biotechnology Products (OBP) and the Office of Process and Facilities (OPF) in assessing BLAs. The two offices are located within the Office of Pharmaceutical Quality. The MAPP says that OBP and OPF have
Drugs
Celgene has agreed to pay $280 million to settle a False Claims Act suit related to the promotion of two cancer treatment drugs for unapproved uses, according to the Justice Department. The settlement resolves whistleblower allegations brought by former Celgene sales manager Beverly Brown that the company violated the law
Drugs
FDA has sent Eagle Pharmaceuticals a complete response letter on its 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke in conjunction with external cooling methods. The letter asked that the company conduct an additional clinical trial. Currently, Ryanodex is approved for treating malignant hyperthermia in
Drugs
FDA has released the FDA-483 issued following a 6/10-7/18 inspection at Bella Pharmaceuticals, a Chicago, IL, outsourcing facility. The inspection observations were: * failing to establish, write, or follow procedures designed to prevent objectionable microorganisms in drug products required to be sterile; * failing to maintain documented production
Drugs
Eisai has submitted a supplemental NDA for the first-line use of Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor for treating patients with hepatocellular carcinoma (HCC). The submission is based on positive results from the pivotal Phase 3 REFLECT trial. “In this study, lenvatinib was the first systemic therapy
Drugs
A 6/2-9/1/16 FDA inspection at Sage Products, Cary, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 7/17 Warning Letter. Specific violations cited in the letter were: * failing to establish and document the accuracy, sensitivity, specificity, and
Drugs
The International Council on Harmonization (ICH) has developed maintenance procedures for revising the permitted daily exposure of solvents included in its Q3C guidance. FDA says an ICH Web page makes available to the public all recommendations, decisions, and other information related to the revision of the Q3C tables and lists.
Drugs
FDA has posted a guidance on “Generic Drug User Fee Amendments of 2012 — Questions and Answers” that gives FDA’s position on such issues as self-identification, generic drug submission reviews, and inspections and compliance. Questions and answers related to user fee assessments can be found in a separate guidance
Drugs
FDA has issued a guidance, Consumer Antiseptic Wash Final Rule, to help small businesses better understand and comply with a final rule establishing that certain active ingredients used in over-the-counter consumer antiseptic wash products are not generally recognized as safe and effective (GRASE) and thus are not eligible