News Briefs

04/07/2022

Austin Public Health department receives The Compliance Team's immunization, testing quality awards

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The Compliance Team, a CMS-approved national healthcare accreditation organization, announced today that the Austin Public Health department of Austin, Texas has become the nation’s first health department recipient of the firm’s Exemplary Provider Certification program for Immunization and Testing Services.

Sandra Canally,  The Compliance Team’s founder and CEO, said that TCT’s certification programs embrace the ideal that “every patient deserves exemplary care. There is no better example of this being an everyday practice than the Austin Public Health department’s immunization services and their unified approach to health equity. They are truly outstanding.”

The Austin Public Health Immunizations Program is the safety net provider for the uninsured. It offers adult and pediatric immunization services and has two clinic locations, Far South Austin clinic at 405 West Stassney Lane and North Austin St. John clinic at 7500 Blessing Avenue.

Chris Crookham, APH’s immunizations program manager, said the organization wanted an independent assessment of its immunizations program to help them better plan for future events like the COVID-19 public health emergency. “We say we’re good, but I wanted a nationally recognized third party to tell our community how exceptional we are. And now we are recognized as an Exemplary Provider by The Compliance Team,” he said.

TCT’s service-specific certification programs are intended to be utilized by local health departments, pharmacies, physician practices and clinics to ensure that their facilities meet comprehensive quality, safety and efficiency standards covering CDC protocols, manufacturer’s guidelines, vaccine storage, infection control, needle safety and drug interaction, as well as patient scheduling, history and follow-up. Comprehensive, yet simplified, operations-based protocols help empower employees to better deal with everyday workplace challenges, the company said.

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04/07/2022

Enlightened intros Greek Yogurt Cheesecakes

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enlightened cheesecakes

Enlightened is expanding upon its feel-good dessert line with a brand-new collection of products.

The brand is expanding its frozen mini cheesecake line with new Greek Yogurt Cheesecakes, which furthers its mission to create craveable desserts with better nutrition, the company said.

“We’re so excited to build upon our existing cheesecake line with the addition of Greek yogurt, a key ingredient also included in two of our new Sundae Cone flavors,” Enlightened CEO and founder Michael Shoretz said. “Consumers love Greek yogurt for its protein and probiotics. We found that incorporating Greek yogurt adds richness and creaminess to our cheesecakes, and we think it’ll delight our fans.”

Available in two flavors — original and dark chocolate — the cheesecakes, which were inspired by New York City-style cheesecakes, features a graham cracker crust and a dollop of whipped cream.

Packaged in a box with two mini cheesecakes that retails for $5.99, Enlightened’s Greek Yogurt Cheesecakes are available online at EatEnlightened.com and at Lowes Foods, United Supermarkets, Food City and H-E-B.

04/07/2022

Clayton Pharmaceuticals gains FDA nod for generic sucralfate oral suspension

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The words approved in red capitalized letters

Clayton Pharmaceuticals has won the Food and Drug Administration’s blessing for Sucralfate Oral Suspension with Competitive Generic Therapy designation.

The approval of this product, through the initial development of 12 different bioassays that tracked the product's postulated clinical interactions using in vitro biology, marks a paradigm shift in how complex generic drug products can be commercialized without the need for expensive, long-drawn and sometimes non-viable clinical studies, the company said.

The product was developed in collaboration with VistaPharm and Neuheit Pharma Technologies, with testing and analytics support by Absorption Systems and CellPort Software, respectively.

“This ANDA approval using well-designed, scientifically sound in vitro bioassays endorses the use of novel approaches to demonstrate product bioequivalence," said Sid Bhoopathy, president and CEO of Clayton Pharmaceuticals. “It is a proud moment for Clayton and our partners, VistaPharm and Neuheit. We are buoyed by the approval of this product and ready to solve the bioequivalence challenges for the next set of complex products."

“I am proud that the strong collaboration between our companies has resulted in an FDA approval for sucralfate oral suspension," Scott Meyers, CEO of Vertice, said. “Congratulations also for the outstanding operational execution that resulted in us quickly receiving CGT designation for this product following FDA approval."

Sucralfate oral suspension had a market value of $188.5 million, of which $157.9 million represents generic sales, for the 12 months ending December 2021, according to IQVIA.

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04/07/2022

Avet receives FDA OK for generic Diprivan

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Injectables

Avet Pharmaceuticals is offering propofol injectable emulsion, 10 mg/ml, in 20, 50 and 100 ml single patient-use vials, following approval of the drug by the Food and Drug Administration.

The medication is the generic of Fresenius Kabi’s Diprivan.

“The approval of Avet's generic propofol injectable emulsion is welcome news to our team, who are prepared to deliver with urgency this much-needed therapy to hospitals and surgical centers, where the product has been in short supply," Marvin Samson, chairman of Avet Pharmaceuticals said. "At Avet, we are committed to delivering high quality generic medicines that help patients and practitioners achieve affordable healthcare solutions. Today's approval announcement is our most recent example of fulfilling that commitment and will serve as an important growth driver for our company."

Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for the initiation and maintenance of monitored anesthesia care sedation, combined sedation and regional anesthesia, induction of general anesthesia, maintenance of general anesthesia, and intensive care unit sedation of intubated, mechanically ventilated patients.

04/07/2022

Nature’s Truth expands adult gummy vitamins

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nature's truth gummy vitamins

Nature’s Truth is rolling out several new gummy vitamins for adults.

The latest launches from the Ronkonkoma, N.Y.-based company are the Magnesium Gummies, Beet Root Gummies, Ceylon Cinnamon Gummies and D3 + B12 Gummies.

“Our primary focus when developing our gummy supplements is on taste, and efficacy,” said Kimberly Vigliante, senior vice president of sales and marketing at Piping Rock Health Products. It’s important to us that we provide our customers with the best-tasting product without sacrificing quality and that we develop unique gummy offerings that align with the latest consumer trends.”

Made to offer enhanced absorption, the Magnesium Gummies also contain a flavor experience. The Ceylon Cinnamon Gummies are sugar-free, the Beet Root Gummies come in a strawberry flavor and the D3 + B12 Gummies also come in a strawberry flavor, the company said.

Nature’s Truth’s new gummy vitamins, which are vegan or vegetarian, non-GMO and gluten free, can be found online at NaturesTruth.com.

04/06/2022

ANI names Renee Tannenbaum to board of directors

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ANI is welcoming Renee Tannenbaum to its board of directors. Tannenbaum has over 35 years of management experience in the pharmaceutical industry. This appointment is effective immediately and increases ANI’s board of directors to nine members.

“We are honored to bring Dr. Tannenbaum’s vast biopharmaceutical commercial experience and expertise to our board of directors. With her many accomplishments and proven track record of developing and implementing innovative commercial strategies, and driving growth, Dr. Tannenbaum will be a great asset to the company, especially as we move forward with our commercialization of Purified Cortrophin Gel,” Patrick Walsh, chairman of the board of ANI, said.

“I am thrilled to join the board of directors at this pivotal point in ANI’s trajectory,” Tannenbaum said. “With the Novitium acquisition completed and the launch of Cortrophin Gel underway, the company has many exciting years ahead, and I look forward to providing my perspectives to management along the way,”

Tannenbaum is a strategic advisor for several biopharmaceutical and device companies, and serves on the Cardiff Oncology board of directors and as a board advisor to Aerami Therapeutics. She was previously vice president of global partnering at Halozyme and head of global customer excellence at AbbVie, where she was responsible for building commercial capabilities for the organization.

Tannenbaum also served as president of Myrtle Potter & Company, a global life sciences consulting and advisory firm, and as executive vice president and chief commercial officer at Elan Pharmaceuticals, where she was responsible for, among other things, revenue generation for Elan’s marketed products, preparing for the commercialization of the company’s pipeline and strengthening its overall commercial capabilities. Prior to her role at Elan, Tannenbaum was at Novartis Pharma AG, where she led the global commercial operations organization. She also spent nine years at Bristol Myers Squibb and 16 years at Merck, where she had a variety of leadership positions.

Tannenbaum, who previously served on the boards of Zogenix, Nordic Nanovector ASA, Cipher Pharmaceuticals, Sharps Compliance and Immune Pharmaceuticals, retains a faculty position at the University of the Sciences’ Mayes College of Healthcare Business and Policy. Tannenbaum received her doctor of pharmacy degree from the Philadelphia College of Pharmacy and Sciences, her MBA from Temple University and her bachelor of science degree in pharmacy from the University of Connecticut.