Betaxolol Hydrochloride

NEWTOWN, Pa., Sept. 29, 2023 /PRNewswire/ -- Company Contact: Name: Susan DiCroce Phone Number: (215) 579-1842 Ext: 1260 Continue Reading Betaxolol HCl Tablets, USP 10 mg Oxycodone HCl Tablets, USP 5 mg Betaxolol Tablets, USP 10 mg Digital Photo of the Principal Display Panel KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; "the batch") of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed "K" above bisect "13" on one side and plain on the other side" to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time. Risk Statement: Risk statement: The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol. Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk. Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product. Consumers with questions regarding this recall can contact KVK-Tech Inc., at (215) 579-1842 Ext: 6002 Monday – Friday, 8:00 am – 6:00 pm EST or by email at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. SOURCE KVK Tech, Inc.

Leadership Addition Strengthens Company's Commitment to Advancing Innovative Therapies NEW YORK, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce that it has appointed William A. Clementi, Pharm.D., FCP as Chief Development Officer. Dr. Clementi will formally take up the CDO role effective September 1, 2023. In this role, Dr. Clementi will be responsible for overseeing the company's development strategies and advancing its portfolio of groundbreaking therapeutic candidates. Dr. Clementi brings with him a wealth of experience in the biopharmaceutical industry, having held leadership roles at several prominent companies. He has a proven track record of successfully guiding development programs from early stages through clinical trials, regulatory approval, and commercialization. His deep understanding of drug development and his strategic insights will be invaluable as Tiziana continues to advance its pipeline. Dr. Clementi has followed a science-driven career path since completing his NIH Training Fellowship (under John L. McNay M.D. and Thomas M. Ludden Ph.D.). Upon completing his Fellowship research in drug metabolism and vascular smooth muscle relaxation, Dr. Clementi joined the University of Texas Graduate School of Biomedical Sciences (UTGBS) faculty and the College of Pharmacy faculty in Austin, Tx, in the Departments of Medicine and Pharmacology at the Health Sciences Center in San Antonio. His primary responsibilities were interdisciplinary, and he led innovative programs in the Colleges with teaching, research, and clinical commitments. Dr. Clementi directed the Clinical Pharmacokinetic Consultation Service, providing novel computer-based drug dosing to the acute care settings at two major teaching hospitals. Dr. Clementi continued his career in the pharmaceutical industry, joining Synthelabo and the U.S. affiliate Lorex Pharmaceuticals, where he held the Worldwide Director of Market Development position. Lorex and Synthelabo launched three EMA and FDA-approved products (betaxolol, zolpidem, and alfuzosin). In 1991 Dr. Clementi established a regulatory consulting company, Clementi & Associates, Ltd. (dba as Clementi Ltd). Clementi Ltd. provides regulatory and clinical consultation to small companies developing drugs, biologics, cell-based therapies, organ sustainability products and contrast media for medical imaging. Clementi Ltd. has experience with required regulatory submission standards and processes, including orphan designation, exploratory INDs, expanded access INDs, and combination drug-drug and device-drug products. Clementi Ltd also provides high-level cGMP and GCP oversight. Dr. Clementi is a graduate of Boston University and the University of Texas and the College of Pharmacy. Commenting on his new role, William A. Clementi said, "I am excited to join Tiziana Life Sciences and contribute to the advancement of its innovative therapeutic candidates. I am excited to apply my regulatory and drug development experience and skills to Tiziana and contribute to the leadership team. The company's commitment to addressing unmet medical needs and its dedication to scientific excellence are truly inspiring. I look forward to working closely with the talented team at Tiziana to drive the development of novel treatments that have the potential to make a meaningful impact on patients' lives." Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, expressed his enthusiasm about the appointment, stating, "We are delighted to welcome William to Tiziana as our Chief Development Officer. His extensive experience and leadership in drug development align perfectly with our company's vision to bring transformative therapies to patients in need. As Tiziana enters a critical phase of growth and development, William's expertise will undoubtedly contribute to our success." About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favourable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379email: info@tizianalifesciences.com Investors:Irina KofflerLifeSci Advisors, LLC+1 646 970 4681ikoffler@lifesciadvisors.com