Drugs
FDA says its review of listing information provided by RPK Pharmaceuticals, Union City, CA, for its clotrimazole and betamethasone dipropionate cream determined that the firm submitted a label for the drug that does not match the name of the listed drug. A 3/26 Warning Letter says the agency previously
Drugs
FDA has released the FDA-483 issued following a 12/1/20-1/28/21 agency inspection at Wells Pharmacy, a Dyersburg, TN, outsourcing facility. The inspection’s seven observations were: * failing to thoroughly review the failure of a batch or any of its components to meet any of its
Drugs
Two Troutman Pepper attorneys cite four FDA March Warning Letters to companies selling CBD products as evidence that the agency is taking a strong stance on product labeling and marketing efforts involving health claims about CBD. Their online post also says that two of the four letters cited companies for
Drugs
FDA says A-S Medication Solutions announced 4/2 a recall of acetaminophen extra strength 500 mg tablets in 100 count bottles contained in health essentials kits distributed by Humana because they contain an incomplete prescription drug label rather than the required OTC drug facts label. An agency statement says
Drugs
Public Citizen has called on HHS secretary Xavier Becerra to have the department Office of Inspector General (OIG) immediately investigate the “unprecedented and inappropriate close collaboration between FDA and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab.” In a 4/1 letter, the
Drugs
Novartis says an FDA draft guidance, Human Gene Therapy for Neurodegenerative Diseases, should leverage past learnings from small molecule, biologic, and current gene therapy experiences to develop a platform approach to support regulatory decision-making. The company comment letter says well-characterized common attributes shared across programs can facilitate the
Drugs
Writing in a Washington Legal Foundation Legal Opinion Letter, three Sidley Austin attorneys say a recent 4th Circuit Court of Appeals decision in a case involving Boehringer Ingelheim’s blood thinner Pradaxa clarified the need to ensure that a conclusion about a drug’s risks has been reached by a
Drugs
FDA has approved a Supernus Pharmaceuticals NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Qelbree is not a controlled substance, the company says. In 12/2020, Supernus announced positive results from a Phase 3 trial
Drugs
CDER has released a final guidance entitled Development of Abbreviated New Drug Applications During the Covid-19 Pandemic — Questions and Answers. The document provides general recommendations to ANDA applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and
Drugs
FDA has issued Acadia Pharmaceuticals a complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis (DRP), indicating that the submission cannot be approved in its present form. “Despite prior agreements with the [FDA] Division of Psychiatry regarding the pivotal
Drugs
Bristol-Myers Squibb (BMS) has agreed to pay the U.S. Government and participating states a total of $75 million to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program. The settlement resolves allegations that BMS underreported the “Average Manufacturer Prices (AMPs)” for a number
Drugs
FDA says using Abbyy’s digital intelligence platform to analyze drug safety reports will save agency reviewers about 7,500 hours per year. An online GCN post says the platform transforms up to 120 fields in safety reports on potential adverse interactions during clinical drug trials into structured content that
Drugs
FDA says Apotex is recalling three lots of Guanfacine extended-release tablets 2 mg due to trace amounts of Quetiapine fumarate in one lot. A company announcement published by FDA says the administration of contaminated tablets can result in hypersensitivity reaction and may have additive effects in lowering blood pressure,
Drugs
FDA has approved Sanofi’s Sarclisa (isatuximab) for combination use with carfilzomib and dexamethasone in treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. The expanded approval was based on data from the Phase 3 IKEMA study, a randomized,
Biologics
Special Counsel Henry Kerner says he agrees with an assertion by former FDA consumer safety officer Arie Menachem that the agency narrowly focused on procedural issues in its response downplaying Menachem’s whistleblower complaints and “disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that
Drugs
Three academics from different universities who participated in the 11/6/20 meeting of the FDA Peripheral and Central Nervous System Drugs Advisory Committee that considered the efficacy and safety of Biogen’s aducanumab for use in treating Alzheimer’s disease say that randomized trials should remain the primary means
Drugs
FDA says its review of study findings showed a potential increased risk of heart arrhythmias in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (GlaxoSmithKline’s Lamictal and generics). An agency drug safety communication says FDA wants to evaluate whether other medicines in the
Drugs
FDA has approved a new indication for Jazz Pharmaceuticals’ Vyxeos (daunorubicin and cytarabine) to treat newly-diagnosed therapy-related acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older. A company statement says approval of the new indication was supported by safety data from two
Drugs
A 9/9-9/27/19 FDA inspection at Tarmac Products, Miami Gardens, FL, found multiple violations in the firm’s manufacturing of over-the-counter drug products and wound dressing medical devices. A just-released 11/9/20 Warning Letter lists violations of current good manufacturing practice (CGMP) regulations
Drugs
The Biotechnology Innovation Organization (BIO) says it encourages FDA to include case study examples in an upcoming public workshop on best practices for the development and application of disease progression models. In a comment letter, BIO says its members are willing to offer case study examples for inclusion in meeting
Drugs
FDA has accepted for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The company says it expects a regulatory decision late in the third quarter. The submission is based
Drugs
Akebia Therapeutics has submitted an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia due to chronic kidney disease in adult patients on or not on dialysis. The submission was prepared in collaboration with Otsuka Pharmaceutical. It includes data from over 8,000 patients