Drugs
FDA says that AuroMedics Pharma is recalling two lots of ampicillin and sulbactam for injection USP 3 grams/single-dose vial to the hospital/user level due to the presence of visible particulate matter. The agency post of a company statement says the recall follows customer complaints about the presence
Drugs
FDA has hinted that it is working on a guidance on manufacturer communications about their products under the First Amendment. In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood noted that there has been great interest in the parameters of a firm’s
Drugs
Serenity Pharmaceuticals has petitioned FDA asking it to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treating nocturia. Serenity is the NDA holder for Noctiva (desmopressin acetate) nasal spray. In the petition, Serenity requests that FDA deny approval because Ferring has not
Drugs
FDA has posted an Akorn Form 483 from a 2016 inspection at the firm’s Zurich, Switzerland sterile drug manufacturing facility. The five-item 483 cited the firm for failing to thoroughly review any unexplained discrepancy. It was also cited for not having the quality control unit’s responsibilities and
Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body. The approval covers the drugs’ use in patients that have a type of abnormal gene,
Drugs
FDA has released the FDA-483 issued following a 12/4-12/12/17 inspection at Akorn AG, Zurich, Switzerland, a finished drug product manufacturer. The four inspection observations were: * failing to establish and document the accuracy, sensitivity, and reproducibility of test methods; * separate or defined areas to prevent contamination
Drugs
FDA has issued a document answering what it says are questions frequently asked by industry about the agency’s clinical data summary pilot program. Questions are answered on what parts of a clinical study report FDA will make available, who redacts information and how that process operates, and who to
Drugs
FDA has released the FDA-483 issued following a 4/17-4/25 inspection at Infuscience, an Eagan, MN, producer of sterile drug products. Inspection observations shown on the form were: * visibly dirty equipment or surface in the ISO 5 classified aseptic processing area; * · personnel moved rapidly in the vicinity
Drugs
Approval times for generic drugs dropped significantly from the first quarter of the fiscal year (10/2017-12/2017) to the second quarter (1/2018-3/2018), according to CDER’s latest Activities Report of the Generic Drugs Program. The quarterly performance report shows that the mean tentative approval time
Drugs
FDA has issued a complete response letter to Sandoz for its BLA for a biosimilar of rituximab (Genentech’s Rituxan), indicated for treating some non-Hodgkin’s lymphomas. The company says it stands behind “the robust body of evidence included in the regulatory submission and is currently evaluating the content
Drugs
FDA has reached an agreement with Alnylam Pharmaceuticals on elements of a Phase 3 study for its lumasiran, an investigational RNAi therapeutic for treating primary hyperoxaluria type 1 (PH1). The company says it and the agency have agreed on a study size of about 25 patients with PH1 and a
Drugs
FDA has issued a guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017, describing the types of user fees authorized by PDUFA 6, the process for submitting payments to FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process
Drugs
The DC District Court has ruled in FDA’s favor to dismiss a suit by the Center for Responsible Science (CRS) that sought new warnings on informed consent documents used in clinical trials. The lawsuit asked the court to force the agency to grant a CRS 6/2014 citizen petition
Drugs
FDA has released the FDA-483 with four observations issued following a 4/16-4/20 inspection at QuVa Pharma, a Temple, TX, drug outsourcing facility. Specific inspection observations were: * the quality control unit lacks authority to fully investigate errors that have occurred; * written records of investigations of a drug
Drugs
FDA says that one dose of InfaCare Pharmaceutical’s stannsoporfin to treat neonates who are at high risk for developing serious complications related to severe hyperbilirubinemia significantly reduced bilirubin levels, but could lead to long-term neurological risk. The assessment is in a briefing document prepared in advance of a
Drugs
FDA has granted Bavarian Nordic an orphan drug designation for its BN-Brachyury vaccine for treating chordoma, a rare cancer that develops along the spine. A Phase 2 study in patients with metastatic chordoma will begin in the second half of this year, enrolling up to 25 patients. An open-
Drugs
FDA has completed a pre-approval inspection of the Biocon sterile drug manufacturing facility in Bangalore, India, and issued an FDA-483 with seven inspection observations. In a filing with the National Stock Exchange of India, Biocon says the inspection observations “are largely procedural and aimed at continuous improvement.” It
Drugs
A Fresenius decision last month to terminate the company’s $4.7 billion merger agreement with generic drug company Akorn was based on alleged “blatant fraud at the very top level” at Akorn, Fresenius said in a recent court filing. Last month, Fresenius said its decision was based on, among
Drugs
The 7th Circuit Court of Appeals issued in March a powerful endorsement of the learned intermediary doctrine in multi-district litigation involving a Zimmer knee implant. Attorney Jonah Knobler (Patterson Belknap) writes in a Washington Legal Foundation Legal Opinion Letter that the court rejected arguments saying that the learned intermediary
Drugs
Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-line results from the Phase 2b STORM study. Data from the study showed that selinexor achieved a 25.4% overall response rate (ORR), which included two
Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, and involvement of lymph nodes, following complete resection. Approval was based on data from COMBI-AD, a Phase 3 study of 870
Drugs
A 3/13-3/23/17 FDA inspection at Fusion IV Pharmaceuticals, a Los Angeles, CA, 503B outsourcing facility doing business as Axia Pharmaceuticals, found multiple violations, including that drug products produced by the firm failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic