Drugs
FDA has lifted a clinical hold on a Cara Therapeutics adaptive pivotal trial of intravenous (IV) CR845 for postoperative pain. “A protocol-specified stopping rule, based on elevated serum sodium levels greater than 150 mmol/L, was met during the first phase of the study, and a review of unblinded
Drugs
FDA has released safety labeling changes 35 drugs that were approved 3/2016, including a Contraindication for hypersensitivity in Janssen’s Invega (paliperidone) extended-release tablets and extended-release injectable suspension, Janssen’s Invega Trinza (peliperidone/palmitate) extended-release injectable suspension, and Janssen’s Risperdal (risperidone) tablets, oral solution, and
Drugs
A 12/1-4/14 FDA inspection at Sri Krishna Pharmaceuticals Unit 2 in Hyderabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 4/1 Warning Letter. Specific violations noted during the inspection included: failing to ensure that laboratory records
Drugs
FDA has posted a draft guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls (CMC) Information” that provides recommendations on implementing a CMC postapproval change under a comparability protocol (CP). “Submission of a CP in an original application or prior approval supplement (PAS) allows the agency
Drugs
Allergan says that a revised FDA draft guidance on cyclosporine has improved, in certain important aspects, the scientific rigor of analyses suggested in the earlier version, but still leaves open some “fundamental gaps that prevent the 2016 draft guidance from describing in vitro analyses that could be adequate on their
Drugs
FDA has approved an Avedro NDA for its Photrexa Viscous, Photrexa and the KXL System for corneal collagen cross-linking for treating progressive keratoconus. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking. Keratoconus is a progressive thinning and distortion of
Drugs
FDA commissioner Robert Califf and associate deputy commissioner for medical products and tobacco Rachel Sherman say that FDA is involved in developing a national system for evidence generation that can improve the ways in which scientific evidence to support medical product evaluation and clinical care decisions is generated. Writing in
Drugs
CDER deputy director for science operations Richard Moscicki says that FDA’s breakthrough therapy designation for new drugs often is misinterpreted by the media or consumers to mean that the drug has already been conclusively shown to be a major game-changing advance. “What I’d like the public to
Drugs
Heron Therapeutics says it has begun labeling discussions with FDA over an NDA resubmission for its Sustol (granisetron) extended release injection, indicated for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The original user fee goal
Drugs
FDA has sent Chiasma, Inc. a complete response letter (CRL) on its NDA for Mycapssa (octreotide) capsules for the maintenance treatment of adult patients with acromegaly. Upon completing its review, the agency told the company that the submission had not provided substantial evidence of efficacy to warrant approval and that
Drugs
FDA’s Nonprescription Drugs Advisory Committee has unanimously (12 to 0) voted to support approval for a Galderma Labs application seeking over-the-counter marketing of Differin (adapalene gel 0.1%) for treating acne in consumers ages 12 years and older. Some panel members said that a proposed Drug Facts
Drugs
Hospira has recalled one lot of 50% magnesium sulfate injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL single-dose vials (Lot 50-343-DK, Expiration 2/1/2017, NDC 0409-2168-02) due to a confirmed customer complaint involving particulate matter present in one vial. A
Drugs
DEVICES FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and
Drugs
Congressman Ted W. Lieu (D-CA) has introduced two bills that would place additional requirements on medical device makers when they make certain changes to their devices. The bills are in response to a yearlong investigation he requested by the House Committee on Oversight and Government Reform that found significant
Drugs
Total prescription drug spending in the U.S. reached $310 billion in 2015, up 8.5% from the previous year, according to a new report by IMS Institute for Healthcare Informatics. “The savings from branded medicines facing generic competition were relatively low in 2015, and the impact of price increases
Drugs
Eight days after its 510(k) was cleared, Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm has filed a petition to FDA seeking the immediate reclassification of Advanced Surgical Concepts’ Pneumoliner power morcellation tissue containment device. The petition asks commissioner Robert Califf to require the device to meet premarket
Drugs
The Generic Pharmaceutical Association (GPhA) says that FDA should deny a 12/16/15 AbbVie petition asking the agency to require specific criteria before designating any product as an interchangeable biologic. AbbVie had called on FDA to require: that interchangeability be established in each condition of use for which the
Drugs
An Unger Consulting review of Warning Letter trends in the first half of FY 2016 finds that FDA is continuing an “intense focus” on compounding pharmacies and outsourcing facilities, which received more than half of the Warning Letters. The analysis asks whether the focus on compounding pharmacies and outsourcing facilities
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA for Opdivo that seeks approval for an expanded use in patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application includes data from the company’s CheckMate-205 study, which evaluated the drug in cHL patients who have received an
Drugs
Repros Therapeutics says new Phase 2 clinical data show that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, a key symptom of uterine fibroids. “When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is
Drugs
Shire has submitted an NDA for a chewable tablet formulation of Vyvanse (lisdexamfetamine dimesylate) for treating attention-deficit/hyperactivity disorder patients who may have difficulty swallowing or opening a capsule. The submission is based on data from two clinical pharmacology studies that demonstrated the chewable tablet formulation is bioequivalent to
Drugs
Members of the FDA Nonprescription Drugs Advisory Committee will be asked 4/15 to comment on a Galderma sNDA for a full prescription to OTC switch for its acne drug Differin (adapelene gel 0.1%) as a once daily topical application. A staff briefing document released in advance of the