News Briefs

04/11/2022

ANI intros generic Cytotec

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White pills spilling out of a medicine bottle

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.”

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04/08/2022

Amphastar gets FDA nod for generic Ganirelix

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Binder with FDA Approved

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.

04/08/2022

Blue Bunny intros Twist Cones

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blue bunny twist cones

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.

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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.

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.