Drugs
FDA has published a draft guidance, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act, describing the agency’s interpretation of, and policies concerning, the prohibition on wholesaling compounded drugs in Section 503B of the Federal Food, Drug, and Cosmetic Act. The document also describes
Drugs
FDA has approved Bayer’s Ultravist (iopromide)-300 and Ultravist-370, iodine-based contrast agents for contrast-enhanced mammography. The company says the products are intended to be used to visualize known or suspected breast lesions in adults, as an adjunct to mammography or ultrasound. Bayer says the indication “aligns
Drugs
FibroGen is discontinuing its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline data from the earlier ZEPHYRIS-1 Phase 3 trial did not meet the primary or secondary endpoints. The primary endpoint was a change from baseline in forced vital capacity at week
Drugs
FDA has approved a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areata. The kinase inhibitor is designed to inhibit Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases. Approval was based
Drugs
FDA has lifted a clinical hold on a Pharvaris deucrictibant clinical trial for the on-demand treatment of hereditary angioedema (HAE) attacks. There still remains a hold on a separate trial for the drug’s prophylactic treatment of HAE, which the company says it will address when it submits data
Drugs
Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor agonist (GLP-1-RA) anti-diabetes candidate lotiglipron due to liver injury concerns and will instead “continue to progress one oral late-stage” GLP-1-RA candidate, danuglipron, toward further clinical development for treating adults with
Drugs
FDA has posted a draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations.” The document provides general considerations to sponsors developing psychedelic drugs for treating such medical conditions as psychiatric and substance use disorders. Under the guidance, the term psychedelic is used as “shorthand to include classic psychedelics, typically understood
Drugs
FDA has issued Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid (OCA) for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The letter told Intercept that any NDA resubmission would require, at a minimum, successful completion of the long-term outcomes phase of
Drugs
Jazz Pharmaceuticals has filed a 6/22 lawsuit in the DC federal court against FDA, seeking to reverse the 5/1 approval of Avadel CNS Pharmaceuticals’ Lumryz, a sodium oxybate drug product citing Jazz’s Xyrem as the reference-listed drug, indicated for treating cataplexy or excessive daytime sleepiness in
Drugs
The attorneys general of 13 states are urging FDA to include the use of in-home opioid disposal products in its approach to opioid disposal. Responding to an agency request for information on in-home opioid disposal systems, the attorneys general of South Carolina, Idaho, Alabama, Indiana, Alaska, Iowa, Arkansas,
Drugs
Senator Marco Rubio has written FDA commissioner Robert Califf to question the agency’s decision to temporarily permit the importation of unapproved cisplatin, an important chemotherapy drug in short supply in the U.S., from China’s Qilu Pharmaceutical. “As the FDA works to alleviate these shortages, it must carefully
Drugs
FDA has published a draft guidance, Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act, with recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical disputes between CDER and requestors and sponsors of
Drugs
Indian drug companies are holding monthly meetings to share FDA-483s that have been received after inspections and their responses to the inspection observations to improve compliance. Bloomberg’s BQ Prime reports that the companies are acting as FDA ramps up inspections in India following a determination that Indian companies
Drugs
A 10/2022 FDA inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL resulted in a just-posted seven-item Form FDA-483. During the inspection, agency investigators cited the firm’s quality control unit because it lacked the authority to review production records to assure that no errors
Drugs
FDA has approved Sebela Pharmaceuticals’ Suflave (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) for colonoscopy preparation in adults. The company says Suflave is a low-volume, safe and effective colonoscopy preparation with a taste similar to a lemon-lime sports drink that was
Drugs
Novartis says it welcomes FDA efforts to draft a guidance for pharmacogenomics (PGx) work and submission in the context of drug development. The company’s comment letter says the guidance as drafted “would significantly influence the way we report exploratory pharmacogenomic research.” It asks for further FDA guidance on the
Drugs
The Physicians Committee for Responsible Medicine is petitioning FDA to require that all product packaging and labeling for glucagon-like peptide-1 (GLP-1) receptor agonists disclose that a plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, weight loss
Drugs
A 9/19-10/26/2022 FDA inspection at Chicago Cornea Consultants in Highland Park, IL, found “objectionable conditions” in the conduct of two clinical investigations. A 6/14 Warning Letter says the inspection was part of the agency’s Bioresearch Monitoring Program. The Warning Letter says specific violations were:
Drugs
Pieris Pharmaceuticals says its partner AstraZeneca has decided to discontinue and stop dosing in the clinical study of elarekibep, an inhaled IL-4 receptor alpha inhibitor being developed to treat asthma. A Pieris statement says the decision was based on lung findings from a non-clinical 13-week GLP toxicology
Drugs
FDA has issued a complete response letter to Aldeyra Therapeutics for its 505(b)(2) NDA for ADX-2191 (methotrexate for injection), an investigational drug candidate to treat primary vitreoretinal lymphoma (PVRL). A company statement says that while no safety or manufacturing issues were identified, the agency stated that there
Drugs
A report produced by the Brookings Institution’s Hamilton Project offers a policy intervention with three components to help address shortages of generic sterile injectable (GSI) drugs. The report says shortages of GSI drugs “compromise patient care in emergency rooms and intensive care units, in cancer treatment, and during elective
Drugs
FDA has approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments, in addition to diet and exercise, for improving blood sugar control in children 10 years and older with Type 2 diabetes. Empagliflozin works by increasing glucose excretion in the urine, according to an FDA