gastric ulcer benign

Danziten is set to be available soon via Biologics by McKesson and Limited Specialty Distribution. Credit: Motortion Films via Shutterstock. The US Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals’ Danziten (nilotinib), the first and only nilotinib formulation that does not require mealtime restrictions, to treat chronic myeloid leukaemia (CML). It is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase, as well as those who are resistant or intolerant to previous therapies that included imatinib. Danziten’s reengineered formulation is said to provide equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage. Its approval is expected to enhance patient adherence to treatment, as it eliminates the need for fasting, which has been a challenge with current therapies. While Tasigna, the existing nilotinib treatment, has proven efficacy for Ph+ CML in chronic and acute phases, its bioavailability is affected by food intake, necessitating strict fasting to prevent cardiotoxicity. An optimal tyrosine kinase inhibitor therapy may lead to deep molecular responses, and for some patients, even treatment-free remission, the company noted. Azurity Pharmaceuticals CEO Richard Blackburn said: “Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna. “Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions.” Danziten is set to be shortly available via Biologics by McKesson and Limited Specialty Distribution. In September this year, the FDA approved the company’s Nymalize , an oral solution provided in a 5ml prefilled ENFit syringe as an alternative for adult subarachnoid haemorrhage patients. In 2022, it received approval for Konvomep, a treatment for active benign gastric ulcers and risk reduction of upper gastrointestinal bleeding in critically ill patients.

Nymalize is indicated for use in adult patients with subarachnoid haemorrhage from ruptured intracranial berry aneurysms. Credit: Radiological imaging/Shutterstock. Azurity Pharmaceuticals’ Nymalize (nimodipine) oral solution in a 30mg/5ml prefilled ENFit syringe has received US Food and Drug Administration (FDA) approval. The ready-to-use prefilled syringe offers an additional layer of security for both patients and healthcare professionals when administering medication. The oral solution in the prefilled ENFit syringe offers an effective alternative for adult subarachnoid haemorrhage patients who are unable to swallow capsules. The adoption of ENFit connectors, which are recommended by the FDA, is said to be on the rise, with around 60% of acute care facilities in the US making the switch from traditional nasogastric tubing. Nymalize improves neurological outcomes by reducing the incidence and severity of ischemic deficits in adults with subarachnoid haemorrhage from ruptured intracranial berry aneurysms. See Also: RegenxBio touts positive data for rare disease drug RGX-121 Ocaliva approval in Europe withdrawn following data re-assessment It is suitable for patients across a range of post-ictus neurological conditions, classified from Hunt and Hess Grades I to V. The Nymalize prefilled ENFit syringes (30 mg/5 ml), along with prefilled oral syringes (30 mg/5 ml and 60 mg/10 ml) and 8 oz (237 ml) bottles will soon be available for order through pharmaceutical wholesalers. Azurity Pharmaceuticals CEO Richard Blackburn stated: “Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines. “Delivering Nymalize with ENFit syringes may offer patients and healthcare professionals a more secure, reliable drug administration through standardisation.” In September 2022, the FDA granted approval for Azurity’s Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcers .

MIAMI, Sept. 7, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Azurity Pharmaceuticals (formerly CutisPharma) in developing the brand name KONVOMEP™, which was approved by the FDA on August 30, 2022. KONVOMEP™ (omeprazole and sodium bicarbonate for oral suspension) is a medication indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill adult patients. Azurity Pharmaceuticals reports that KONVOMEP is expected to become commercially available in pharmacies nationwide in Q1 of 2023. Azurity Pharmaceuticals is a pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked patients. Azurity Pharmaceuticals' products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. "The entire Brand Institute and Drug Safety Institute Team congratulates Azurity Pharmaceuticals on the FDA approval of KONVOMEP," said Brand Institute's Chairman and C.E.O., James L. Dettore. About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 4,000 marketed healthcare brand names, 1,300 USAN/INN nonproprietary names for 1,200 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling. Contact: James Dettore Chairman & C.E.O. [email protected] SOURCE Brand Institute, Inc.