Ditiazem Hydrochloride

The recall initiated by Glenmark on 26 March is intended for the affected lot produced in India. Credit: Fahroni/Shutterstock.com. Glenmark Pharmaceuticals’ US-based unit has announced the recall of 6,528 bottles of Diltiazem Hydrochloride extended-release capsules for treating high blood pressure. As per the US Food and Drug Administration’s (FDA) latest Enforcement Report, the recall has been classified as Class II. As the medication did not meet the dissolution specifications, it prompted the recall in the US market. The recall initiated by Glenmark on 26 March is intended for the affected lot produced in India. According to the US FDA, the issue was identified as “Out of Specification (OOS) results in a dissolution test at the 12-month time point during a long-term stability study.” See Also: AVEO Pharmaceuticals gets grant for decreasing blood urea nitrogen levels in hyperuricemia using anti-gdf15 antibody Allscripts Healthcare Solutions gets grant for resource management system for medical software applications optimization A Class II recall is defined by the FDA as a case where the usage or exposure to a violative product could lead to temporary or medically reversible adverse health consequences, or where the possibility of serious adverse health outcomes is remote, news agency PTI noted. India holds a significant position in the global pharmaceutical market, being the largest supplier of generic medicines. The country contributes approximately 20% to the global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories. The pharmaceutical products manufactured in India are exported to more than 200 countries, with key destinations including Australia, Japan, western Europe and the US. Notably, India is home to the highest number of US FDA-compliant pharma companies with plants outside the US. In September last year, Glenmark Pharmaceuticals signed a definitive agreement to divest a 75% stake in its Glenmark Life Sciences division (GLS) to Indian company Nirma for Rs56.51bn ($679.85m). GLS focuses on manufacturing active pharmaceutical ingredients.

TAVT-45 (abiraterone acetate) Oral Suspension: Phase 3 Trial Demonstrates Therapeutic Equivalence Between TAVT-45 and Zytiga® with a Comparable Safety Profile, Suggesting the Potential of TAVT-45 as an Alternative to Zytiga® for Metastatic Prostate Cancer Patients Who Have Difficulty Swallowing (Dysphagia) TAVT-119 (amlodipine besylate) Gel: Results from Phase 2 Study Demonstrate that Topical TAVT-119 Treatment was Well Tolerated and Showed Promise in Reducing Pain in Patients with Anal Fissure KING OF PRUSSIA, Pa., May 31, 2023 /PRNewswire/ -- Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company, today announced that it will present new data from its metastatic prostate cancer program during the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago, as well as from its anal fissure program during the upcoming American Society of Colon and Rectal Surgeons (ASCRS) Annual Meeting being held June 3-6 in Seattle. "At ASCO, we will present detailed Phase 3 results for TAVT-45 that further demonstrate its potential to become the first FDA-approved oral suspension formulation of abiraterone acetate for patients with metastatic prostate cancer and provide a much-needed alternative for patients with dysphagia," said Andreas Maetzel, M.D., Ph.D., Chief Medical Officer of Tavanta Therapeutics. "At ASCRS, we are excited to present the first data from our Phase 2 study of TAVT-119 in people with anal fissure. Currently, non-surgical options to treat anal fissures include topical nitrates (which are limited by headache/tolerability) and topical calcium channel blockers (which are only available via compounding pharmacies as none are FDA-approved for anal fissure). Based on the data that will be presented, we believe that TAVT-119 has the potential to offer patients a therapeutic option that is safe, efficacious and accessible." "We are pleased to highlight these promising new data, which reflect the significant progress of our clinical development programs," said Lynne Powell, Chief Executive Officer of Tavanta Therapeutics. Details of presentations are as follows: ASCO Presentation Poster: A Novel Abiraterone Acetate Oral Suspension for Patients with Metastatic Prostate Cancer: An Open-Label, Phase 3, Randomized Trial Poster Number: 146 Date: Saturday, June 3, 2023 Poster Session Time: The poster will be presented from 8:00 – 11:00 a.m. CDT, during the "Genitourinary Cancer—Prostate, Testicular, and Penile" poster session The Company's abstract, which has been made available on the ASCO website can be viewed here. For more information about ASCO visit . ASCRS Presentation Poster: Phase 2 Study of TAVT-119 (amlodipine besylate) Gel in Patients with Chronic Anal Fissure Poster Number: eP600 Date: Monday, June 5, 2023 Poster Session Time: An oral presentation of the ePoster will occur from 11:25 – 11:30 a.m. PDT, during the "ePoster Monitor 16 Benign Anorectal Disease" session The Company's abstract will be made available after the presentation on Tavanta's website. For more information about ASCRS visit About Prostate Cancer and TAVT-45 Granules for Oral Suspension Prostate cancer is the second leading cause of cancer in men.1 TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), is an enhanced formulation of abiraterone acetate, an androgen biosynthesis inhibitor. Abiraterone acetate is currently marketed in the U.S. and EU as Zytiga® tablets for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 may provide an alternative for 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets. Other limitations of the commercially available abiraterone tablets include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure can result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.2,3 It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients with sub-optimal abiraterone trough plasma concentrations. About Anal Fissures and TAVT-119 Gel Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms, and are quite common in the general population.4 TAVT-119 is a novel topical formulation of amlodipine, a long-acting calcium channel blocker (CCB) that can relax smooth muscle and improve vasodilation. Amlodipine is currently marketed in the U.S. and EU as Norvasc® tablets for treating hypertension and coronary artery disease. TAVT-119 gel is under development for treating moderate to severe pain associated with anal fissure. Current non-surgical treatment options for anal fissure include topical nitrates and CCBs. However, topical nitrates are associated with side effects such as severe headaches, while CCBs are not approved in the U.S. to treat anal fissures and are often used off-label via compounding pharmacies.4,5 TAVT-119 has the potential to become the first FDA-approved CCB for anal fissure, which could overcome access/availability issues of compounded agents, with fewer adverse events expected compared to topical nitrates. About Tavanta Therapeutics Tavanta Therapeutics (Tavanta), headquartered in King of Prussia Pa., is a clinical-stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with serious or debilitating diseases. Tavanta has developed a risk-balanced approach to discovery and product development by both enhancing the clinical performance of established molecules and synthesizing novel small molecules and therapeutic peptides. For more information, visit and connect with us on LinkedIn. References: 1. Key Statistics for Prostate Cancer. American Cancer Society. 2. Carton E, Noe G, Huillard O, et al. Relation between plasma trough concentration of abiraterone and prostate-specific antigen response in metastatic castration-resistant prostate cancer patients. Eur J Cancer. 2017;72:54-61. 3. van Nuland M, Groenland SL, Bergman AM, et al. Exposure-response analyses of abiraterone and its metabolites in real-world patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020;23(2):244-251. 4. Davids JS, Hawkins AT, Bhama AR, et al; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anal Fissures. Dis Colon Rectum. 2023 Feb 1;66(2):190-199. 5. Shah M, Sandler L, Rai V, et al. Quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissure. World J Gastroenterol. 2013 Sep 14;19(34):5645-50. Contacts: Corporate: Lynne Powell, CEO [email protected] Media: Elixir Health Public Relations Lindsay Rocco +1 862-596-1304 [email protected] SOURCE Tavanta Therapeutics