News Briefs

Eton Pharmaceuticals has received the green light from the Food and Drug Administration for cysteine hydrochloride.

The medication is the generic of Exela Pharma Sciences’ Elcys.

Eton was granted 180 days of generic exclusivity as a result of being the first ANDA submitted against the reference product. The 180-day exclusivity period will begin upon Eton’s commercialization of the product.

“We are pleased to see another one of our products receive FDA approval," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "Despite Exela’s attempts to monopolize a decades old treatment with patents that we believe to be frivolous, we are eager to provide a lower cost product to newborn infants that need cysteine.”

Cysteine is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants. Prior to 2019, cysteine was sold in the United States as a “grandfathered” or “unapproved” product. In 2019, Exela Pharma Sciences received FDA approval of its product, which contains the same formulation as the “grandfathered” versions, and Exela Pharma Sciences more than tripled the price of the product to its current price of $82 per vial from the “grandfathered” product price of $22, the company said.

The company also said that Eton’s partner has manufactured the product in its current formulation as far back as 2003, well before Exela Pharma Sciences began working on its product or filed its patent, and as a result, Eton believes Exela’s patents are invalid and should not have been issued by the United States Patent and Trademark office.

Eton is currently engaged with Exela in paragraph IV litigation regarding the validity of Exela’s cysteine patents. The trial was held in March 2022 and the company expects a decision from the judge in the third quarter of 2022.

Cysteine injection has a market value of $50 million annually, according to IQVIA.

 

Blue Bunny is bringing the taste of soft serve right to consumers’ homes.

The Chicago-based company is unveiling its new Twist Cones, which come in three classic flavors inspired by soft frozen dairy twisted all the way to the bottom and ending with a chocolatey bite in each cone, according to the brand.

“We’re super excited to launch this disruptive innovation bringing the fun of soft serve into homes across America, and the response has been outstanding. Eight-eighty percent of consumers who tried our Twist Cones found them to be different from other cones available at stores today,” said Jeremy Hrynewycz, brand director at Blue Bunny. “We love bringing the fun of Blue Bunny to consumers' homes in new and innovative ways, and Twist Cones are this summer’s newest addition to our all-star lineup of frozen treats the whole family can enjoy.”

Available in chocolate vanilla, strawberry cheesecake and chocolate peanut butter flavors, Blue Bunny’s Twist Cones can be found online at bluebunny.com.

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.

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.

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.

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.