Breckenridge has received the Food and Drug Administration’s tentative approval for dabigatran etexilate capsules.
The medication is the generic of Boehringer Ingelheim's Pradaxa.
Pradaxa is used to reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem; treat blood clots in the veins of legs (deep vein thrombosis) and lungs (pulmonary embolism) after treatment with an injectable medicine to treat blood clots for five to 10 days; and reduce the risk of blood clots from happening again in the veins of legs and lungs after a patient has received treatment for blood clots.
Breckenridge said that the product development was a collaboration between Towa Pharmaceutical Europe, S.L. coupled with an external contract manufacturing organization.
Breckenridge has the three strengths consistent with the brand — 75 mg, 110 mg and 150 mg.
Pradaxa had a market value of $455 million during the 12 months ending February 2022, according to industry data, the company said.
The Association for Accessible Medicines is welcoming a new member.
Meitheal Pharmaceuticals, a fully integrated generic injectables company based in Chicago, has joined the organization.
“We are proud to partner with AAM in support of our mission to bridge important gaps in health care with an affordable and diversified range of generic injectables,” said Tom Shea, CEO of Meitheal Pharmaceuticals. “We look forward to working together to achieve our shared goal of getting safe, effective and more-affordable medicines out of the lab and into the hands of the people who need them.”
The company primarily specializes in the development, manufacture, procurement and sale of generic injectable pharmaceuticals, with 36 FDA-approved products covering indications for anti-infective, oncolytic and intensive care.
“Meitheal’s active engagement in AAM makes our voice even stronger and more effective as we advocate on behalf of the generic industry and its mission to ensure that our quality, safe, effective and affordable medicines are accessible to America’s patients,” said Dan Leonard, CEO of AAM. “We are pleased to welcome Tom Shea’s participation on our board of directors alongside his industry peers.”
Furthermore, Meitheal has an expanding product portfolio and robust pipeline, including single and multidose vials, ready-to-use prefilled syringes and premixed bags. As of the end of March 2022, Meitheal had 49 products in the research and development phase, 24 products were under review by the Food and Drug Administration, and 16 products were planned to be launched in 2022, the company said.
Teva settles patent dispute with Lupin on generic Austedo
Teva Branded Pharmaceutical Products R&D and Auspex Pharmaceuticals, U.S., affiliates of Teva, have reached an agreement with Lupin to resolve the dispute over Lupin’s ANDA for a generic deutetrabenazine product. Teva and Lupin have been involved in a patent infringement litigation in which Teva asserted a number of patents against Lupin that cover Teva’s Austedo (deutetrabenazine) product.
Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.
Austedo is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease.
Teva said that it believes that today’s settlement with Lupin is a further reflection of the strength of its intellectual property covering its Austedo product.
On March 9, 2022, the U.S. Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex. Teva said that it will continue to litigate the ongoing patent infringement suit it brought against Aurobindo regarding Aurobindo’s ANDA for a generic deutetrabenazine product.
Path to Purchase Institute webinar to address power of retail media
Retail platforms are poised to be the new darling of the media industry — for good reason. However, retail media as a capability is still in its infancy, and not all retail media capabilities are created equal (or effective).
The Path to Purchase Institute will tackle this topic in an upcoming webinar, part of the Institute's Path to Purchase Now 2022 series, with a deep dive into retail media. Speakers Jonathan Lustig, head of revenue at Walgreens Advertising Group, and Andrea D'Emidio, director, omnichannel shopper marketing and e-commerce, at Johnson & Johnson, will discuss how open, integrated access to first-party data and closed-loop reporting create powerful, personalized campaigns and, ultimately, help marketers achieve their campaign goals up and down the funnel.
The webinar will take place on May 10 at 11 a.m. ET. Register now.
Voortman is debuting two new summer-inspired flavors of its well-known, fruit-flavored wafers.
Raspberry lemonade and tropical fruit varieties, which are seasonal flavors, contain the same light, crispy texture the brand has become synonymous with, as well as a creamy filling.
“With summer approaching, consumers are increasingly looking for snacks in sweet, refreshing flavors to enjoy on a warm day,” said Adam Lisook, general manager of Voortman Cookies. “Our raspberry lemonade and tropical fruit wafers contain real raspberries, lemons, pineapple and coconut, and are made without high fructose corn syrup, artificial colors or artificial flavors so consumers can feel good about eating them all season long.”
Available in a 10.6-oz. package, Voortman’s seasonal raspberry lemonade and tropical fruit wafers retail for $3.49 and can be found at retailers across the United States and Canada beginning in May.