FDA approves low-dose appetite suppressant Lomaira
SILVER SPRING, Md. — The Food and Drug Administration has approved KVK Tech’s Lomaira (phentermine HCl), the company announced Tuesday. The drug is indicated for short-term use to aid in weight reduction in obese and overweight patients (patients with body mass indices of 30 or higher and 27 or higher, respectively) with at least one weight-related condition, including high blood pressure and diabetes.
The drug, which is meant to be used alongside a reduced-calorie diet and regular exercise, can be taken as many as three times a day before meals, the company said, noting that its aim was to provide an affordable medicine to aid in weight reduction. Patients who qualify for the Lomaira Lo-Cost Access program will pay no more than $0.50 per tablet during treatment.
“At KVK Tech, we are committed to developing high-quality, FDA-approved medicines that address unmet medical needs, while ensuring affordable options for all appropriate patients,” KVK Tech president and CEO “With Lomaira, we're giving physicians and patients access to a low-cost, low-dose version of a weight-reduction medicine, phentermine, that has been prescribed by physicians for over 50 years.”
The company expects Lomaira to be available by the end of September. The drug is available in 8-mg tablets.
"Obesity is a chronic metabolic disease that must be managed appropriately to reduce the risk of serious health conditions," Dr. Donna Ryan said. "Many physicians have used phentermine to help patients as part of a comprehensive weight-management plan. Now, the flexibility in dosing with Lomaira allows doctors to personalize dosing."
Bartell Drugs opens 65th store
SEATTLE — Over the weekend, Bartell Drugs opened its 65th store in Seattle’s Chinatown-International District, holding a grand opening event on Sept. 17. The 11,656-sq. ft. store is seen by the chain as a signature store in its urban expansion and is located across from a commuter and Amtrak train station.
“Bartell Drugs is thrilled to be part of this dynamic neighborhood,” Bartell president and CEO Brian Unmacht said. “Our line-up of great products, convenience and superior red vest service will be a boon to both commuters and area residents alike.”
In addition to a full-service pharmacy, the new store has an expanded cosmetics section aimed at showcasing seasonal and on-trend colors, shades and products. It also has a growler fill spot called Northwest on Tap that showcases local microbrews, and a café. The grand opening festivities included giveaways and a traditional Chinese lion dance.
Bartell Drugs already has its sights set on its 66th location, which it’s planning to open in Seattle’s Ballard neighborhood in October.
Industry responds to Biosimilar User Fee Act letter
SILVER SPRING, Md. — The Food and Drug Administration on Friday released the Biosimilar User Fee Act (II) performance goals letter, drawing support from trade groups representing biotechnology companies.
The letter includes key provisions around improving the efficiency of the FDA review process for biosimilars, promoting engagement between the FDA and biosimilar manufacturers during the development and review process to ensure timely feedback and establishing a dedicated staff capacity for key functions, including facilitating scientific coordination, policy development, operations management, program governance and others. The letter also seeks to help modernize time reporting and capacity planning.
“Since its creation in 2012, BsUFA has helped benefit patient safety and public health as biosimilar products are required to meet FDA's high standards for safety, purity and potency,” the Pharmaceutical Research and Manufacturers of America said. “The BsUFA II agreement will help provide FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients.”
In addition to PhRMA, the letter gained support from the Biotechnology Innovation Organization (BIO), which was “particularly pleased with the Agency’s commitment to establish a program for enhanced communications during the biosimilars review process,” noting that a similar program under the Prescription Drug User Fees Act has been successful in improving communications during the development and approval process.
“We also applaud the agency’s commitment to implement a new time reporting system and to enhance financial transparency, to provide more accurate data on which to base accurate tracking of the use of BsUFA resources and a clear picture of that resource allocation,” BIO said. “The commitments to improve FDA recruitment, hiring and retention of staff necessary to accomplish the goals of the biosimilars program are significant and crucial to the program’s success.”
Both groups said they looked forward to working with the agency, the administration and Congress to reauthorize the act in a timely manner.
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