News Briefs

Yasso released a new frozen Greek yogurt product that consumers will surely find original.

New from the Boulder, Colo.-based company is its Frozen Greek Yogurt Mochi line, which features frozen Greek yogurt wrapped in fluffy rice dough.

Available in chocolate, mango, vanilla and strawberry flavors, each individual gluten-free Mochi contains only 80 calories per serving and is free of artificial ingredients, the company said.

“The launch of Yasso Mochi furthers our position as a leader in frozen snacking as we continue to innovate outstanding new products that marry superior taste and quality nutrition,” said Craig Shiesley, CEO of Yasso. “This new platform allows consumers to reach for Yasso during new occasions and delivers on our brand promise of permissible indulgence, now in a new snackable format.”

Yasso Mochi comes in a pack of six that retails for $5.49 at select retailers nationwide and online at yasoo.com.

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.

 

ANI is launching misoprostol tablets in dosage strengths of 100 mcg and 200 mcg.

The product is the generic of Pfizer’s Cytotec.

Cytotec is indicated for reducing the risk of nonsteroidal anti-inflammatory drugs, including aspirin-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

Misoprostol tablets have a market value of approximately $15.3 million, according to IQVIA.

"We are pleased to announce the launch of AB-rated misoprostol tablets. The AB rating indicates that our product meets necessary bioequivalence requirements, thus is therapeutically equivalent to the RLD,” Nikhil Lalwani, president and CEO of ANI, said. "This rating provides us with an advantage versus other available generics. In light of the recent drug shortage, the commercialization of misoprostol tablets highlights our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers.”

The Food and Drug Administration has given Amphastar the green light for generic ganirelix acetate injection, 250 mg/0.5 ml in a prefilled syringe.

The product is used for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation.

The medication is the generic of Organon Pharmaceuticals' Ganirelix acetate injection.

"Ganirelix is the company's fourth injectable peptide product approval. It represents our capabilities in executing our pipeline while furthering the development of our diabetes product portfolio," Amphastar's president and CEO Jack Zhang said.

The company said it plans to launch ganirelix acetate injection during Q2 2022.

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.