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The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's (4578.T), opens new tab drug in combination with Viatris' (VTRS.O), opens new tab Zoloft for the treatment of adults with PTSD. The FDA staff's assessment comes ahead of a meeting of its independent experts on Friday, who will make recommendations on whether the regulator should approve the use of the drug, brexpiprazole, in combination with Zoloft for treating PTSD. The FDA staff cited inconsistent trial results and a modest treatment effect that may not be clinically meaningful as reasons for the efficacy concerns. Otsuka's application was based on the data from one mid-stage and two late-stage studies testing the combination of brexpiprazole and Zoloft in PTSD patients compared to sertraline monotherapy. The reviewers, however, noted that one of the late-stage studies failed to show statistically significant differences in treatment response between the two groups. They also added that the mid-stage study had statistical and methodological concerns. PTSD is a mental health condition that can develop after a traumatic event, causing symptoms including flashbacks, nightmares and severe anxiety. Brexpiprazole, sold under the brand name of Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer's disease...

KalVista Pharmaceuticals (KALV.O), opens new tab said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading. The regulator's greenlight comes after it extended the review of the drug, Ekterly, due to heavy workload and limited resources. With the approval, Ekterly becomes the first on-demand oral treatment for hereditary angioedema, offering a convenient alternative to injectable treatments. The life-threatening condition causes sudden, dangerous swelling in the body, including the skin, digestive tract and upper respiratory system, due to deficiency in a protein known as C1 inhibitor.

-The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants to treat attention-deficit hyperactivity disorder (ADHD) to warn about the risk of weight loss and other side effects in patients younger than six years. The FDA said that it is requiring a "limitation of use" section in the prescribing information of all extended-release stimulants to include a statement on higher rates of adverse reactions in children younger than six years. ADHD is a disorder, common among children, that affects the ability to pay attention, follow directions and complete tasks. The FDA has approved two types of medications — stimulants and non-stimulants — to help reduce symptoms of ADHD. Stimulants, sold under brand names Ritalin by Novartis and Concerta by Johnson & Johnson's unit Janssen, are commonly prescribed by healthcare professionals. They work by increasing levels of dopamine and norepinephrine in the brain, two neurotransmitters associated with motivation, attention and impulse control. Extended-release stimulants are not approved for children younger than six years, but healthcare professionals can prescribe them "off label" to treat ADHD, the FDA said. The agency said it assessed data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment, finding that,...

Over IRR 180 Billion Worth of Illegal Medicines and Medical Supplies Seized in Mashhad Mashhad – In a major crackdown on pharmaceutical smuggling, Iranian authorities have confiscated over IRR 180 billion (approximately $400,000) worth of illegal medicines and medical supplies in the northeastern city of Mashhad. The operation was carried out by the Food and Drug Administration in cooperation with law enforcement agencies following extensive surveillance and intelligence gathering. According to officials, the seized items included counterfeit, expired, and unregistered drugs, as well as unauthorized medical equipment. These products were being stored in unsafe and unsanitary warehouses, posing a serious risk to public health. Dr. Alireza Marandi, a senior official at the Mashhad Health Department, emphasized the dangers of consuming unlicensed medications, noting that many of the seized products lacked proper labeling, expiration dates, and approval from Iran’s health authorities. “This operation is part of our ongoing effort to eliminate the black market for medicines and to ensure that patients have access to safe and approved pharmaceutical products,” Dr. Marandi said. He also urged the public to avoid purchasing medicine from unregulated sources, especially online platforms or unofficial sellers, and to report suspicious activities to the health authorities. The seized products are currently being examined...

Issued by the Iranian Food and Drug Administration (IFDA) The Public Relations Office of the Iranian Food and Drug Administration has announced the recall and removal of several unauthorized natural, traditional, and dietary supplement products from distribution and sale. The affected products are as follows: Yedik Shot, Batch No. 14031 – Gostarsh Milad Pharmed Prokid Pouya, Batch No. 14035 – Gostarsh Milad Pharmed Parsi Lact – Pardis Roshd Mehregan Soy Menopause – Sabz Darou Espadana Regflor Capsules – Faradaru Fanavar Mehr Well Gut Gum & Gut Tablets – Zist Takhmir Femi Lact Capsules, Batch Nos. 210333 & 210335 – Zist Takhmir