Drugs
Responding to an FDA request for comment on whether the agency should develop a list of pre-1994 ingredients that would be presumed safe for use in dietary supplements under the Dietary Supplement Health and Education Act of 1994, the Center for Science in the Public Interest says it believes
Drugs
FDA has approved a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The company says the product is the first nebulized long-acting
Drugs
Senator Joe Manchin (D-WV) has called on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnecessary and dangerous opioid medications. In a 12/6 letter to FDA commissioner Scott Gottlieb, Manchin offered support for the steering committee. He noted that in the past
Drugs
FDA has issued a draft guidance, Pediatric Rare Diseases—A Collaborative Approach for Drug Development Using Gaucher Disease as a Model, to facilitate drug development in pediatric rare diseases. “In particular,” the document says, “it discusses a new possible approach to enhance the efficiency of drug development in pediatric rare
Drugs
FDA has released the FDA-483 issued following an 11/6-11/11 inspection at Glenmark Pharmaceuticals, a finished dosage manufacturer in Solan, Himachal Pradesh, India. Inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Drugs
FDA has approved a Novo Nordisk NDA for Ozempic (semaglutide) injection 0.5 mg and 1 mg, a once-weekly glucagon-like peptide receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. The company says approval was based on
Drugs
Advocacy group Public Citizen has petitioned FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified by the agency as presenting a significant safety risk in drug compounding. The group says FDA has dragged its feet in adding the drug to the listing, noting
Drugs
The FDA Toxicology Working Group has laid out its Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments of FDA-regulated products. FDA acting chief scientist Denise Hinton writes in an FDA Voice online post with Center for Food Safety and Applied
Drugs
FDA has granted full approval for Genentech’s Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prior therapy. Avastin was previously approved under the agency’s accelerated approval program, which requires confirmatory evidence in order for it to be converted to full approval. The approval decision was based
Drugs
FDA has accepted for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for managing moderate-to-severe acute pain. The agency has set a user fee review target date of 7/28/2018. The submission is based primarily on a
Drugs
The Supreme Court has invited the Solicitor General to submit a brief outlining the views of the United States on Merck’s request that the high court hear its appeal of a 3rd Circuit court decision involving a state law failure-to-warn claim for the company’s Fosamax (alendronate
Drugs
The Los Angeles Times says that researchers who evaluated four FDA programs designed to speed drug approval found that 105 drugs and biologics approved between 1/2012 and 12/2016 went through the approval process with one of four designations intended to speed the path to approval, while 69 medications
Drugs
Writing in the Journal of the American Medical Association, three researchers say the existing drug patent system is poorly designed to motivate discoveries of new uses for off-patent drugs, and suggest other techniques that could be used. “With the long histories, established safety records, and low prices of generic
Drugs
A 6/16-6/22 FDA inspection at Hangzhou Facecare Cosmetics Co., Hangzhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/17 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
Drugs
The Biosimilars Forum is calling on FDA to build appropriate flexibility into a final guidance on statistical approaches to evaluate analytical similarity, taking into account the complexity of the subject matter and its applicability to diverse biosimilar development programs. In its comments on a draft guidance, the group says that
Drugs
South Korean biopharmaceutical company Medytox is petitioning FDA not to approve a Daewoong Pharmaceuticals neurotoxin product that is the subject of an Evolus BLA due to false statements about a botulinum toxin strain and concerns about data integrity and the impact on patient safety. In its petition, Medytox says that
Drugs
FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis (PsA). The therapy was first approved 3/2016 for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval was based on data
Drugs
FDA has approved Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar to Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for breast or
Drugs
Health Research Laboratories and its owner, Kramer Duhon, have agreed to settle charges brought by the Federal Trade Commission (FTC) and the state of Maine that they deceived consumers with promises that their marketed dietary supplements could treat everything from arthritis to memory loss. A proposed federal court order bars
Drugs
FDA has accepted for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for use as a local topical anesthetic. FDA has assigned a user fee review action target date of 7/21/2018. The submission is based on data from two
Drugs
A federal judge has sentenced a Corpus Christi, TX, man to 12 months in prison for selling online and in stores dietary supplements that contained misbranded or unapproved foreign drugs. Elias Trevino Jr. had earlier pleaded guilty to the charges, a government release says. At the time of his guilty
Drugs
The Center for Responsible Science (CRS) is suing FDA in DC federal court to force the agency to grant a CRS 6/2014 citizen petition on improved protections for human subjects in clinical trials. The petition asked that “FDA ensure every prospective trial participant receives the information necessary to evaluate