FDA Approves First Over-the-Counter Naloxone Nasal Spray

Agency Continues to Take Critical Steps to Reduce Drug Overdose Deaths Being Driven Primarily by Illicit Opioids

Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online. 

The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. 

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. 

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”   

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription. 

The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed. 

The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.

Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
The FDA granted the OTC approval of Narcan to Emergent BioSolutions.

Related Information


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Arby’s Orchestrates Harmonious Blend of Sweet And Spicy With New Menu Items

Arby’s King’s Hawaiian Sandwiches and Loaded Fries deliver a flavorful combination of sweet and spicy for a limited time

Sweet or spicy? Thanks to the dynamic duo of Arby’s and King’s Hawaiian, fans can get the best of both worlds. On March 27, Arby’s introduced three unique items with a perfectly balanced blend of sweet and spicy. The new King’s Hawaiian Sweet Heat Sandwiches and Loaded Fries have a symphony of saucy, intricate flavor layered into every bite.

King’s Hawaiian Sweet Heat Chicken Sandwich


The King’s Hawaiian Sweet Heat Sandwiches are available to enjoy in two options – Crispy Chicken and Beef ‘n Brisket. The King’s Hawaiian Sweet Heat Chicken Sandwich is a perfectly balanced blend of opposites: crispy chicken on a soft, sweet King’s Hawaiian bun, covered in sweet and spicy sauce and piled high with cheddar cheese, crispy onions, sweet garlic & dill pickles, lettuce, and tomatoes.

King’s Hawaiian Sweet Heat Beef ‘n Brisket Sandwich


Meanwhile, the King’s Hawaiian Sweet Heat Beef ‘n Brisket Sandwich is a deliciously stacked premium sandwich made from 13-hour smoked brisket and thinly sliced roast beef topped with cheddar cheese, sweet and spicy sauce, crispy onions, and sweet garlic & dill pickles on a toasted King’s Hawaiian bun.

Arby’s New Loaded Fries


Arby’s new Loaded Fries bring everything together with gooey delicious flavor in each bite and are the perfect side dish or snack. Drizzled in the sandwiches’ signature sweet and spicy sauce, the protein-packed Loaded Fries are also topped with warm cheddar cheese sauce, diced crispy chicken nuggets, and chopped bacon.

“Arby’s launched the deliciously spicy Diablo Dare sandwiches and fries last year, and we wanted to build on that success with new menu items that offer a more complex taste by combining two contrasting yet complementing flavors,” said Rita Patel, CMO of Arby’s. “The interplay of sweet and spicy and soft and crunchy in our King’s Hawaiian Sweet Heat Sandwiches and Loaded Fries offers fans a harmony of flavors and textures in every bite, proving that opposites really do attract.”

Guests can enjoy Arby’s King’s Hawaiian Sweet Heat dishes beginning March 27 for a limited time. The new King’s Hawaiian Sweet Heat Chicken Sandwich starts at $7.19, the King’s Hawaiian Sweet Heat Beef ‘n Brisket Sandwich starts at $7.99 and Arby’s new Loaded Fries start at $5.49.

Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Antiseptic and Hand Sanitizer Products Due to Presence of Methanol


Product Type:  Drugs
Reason for Announcement: Due to Presence of Methanol
Company Name:  Jarman’s Midwest Cleaning Systems, Inc.
Brand Name: Midwest Cleaning Solutions, Clean Pro Supply
Product Description: Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution

Company Announcement

Soft Hands CleanproFOR IMMEDIATE RELEASE – Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the presence of methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning. To date, Jarman’s Midwest Cleaning System’s Inc. has not received any reports of adverse events related to these products.

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The products are packaged in 1-gallon clear or white plastic bottles. The product may have been purchased by the 1-gallon bottle, or by the case which contains 4 of the 1-gallon bottles per box. Product information:

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
Non-sterile Solution
Manufacturer / Distributer DOM NDC Volume
Midwest Cleaning Solutions
404 Noid Rd, Canton SD 57013
24 MAR through
None 3.785 L
Clean Pro Supply, LLC
1533 Lyell Ave, Rochester, NY 14606
24MAR2020 through
77518-200-01 1 Gallon,
128 fl oz,
3785 mL
Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer
Non-sterile Solution
Manufacturer / Distributer DOM NDC Volume
Midwest Cleaning Solutions
404 Noid Rd, Canton SD 57013
24MAR2020 through
74663-002-01 3.785 L

Jarman’s Midwest Cleaning System’s Inc. is notifying its distributors by voluntary recall letters and consumers via this press release. Consumers that have the recalled products Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution should stop using and either dispose of it in accordance with local ordinances, or contact Jarman’s Midwest Cleaning Systems, Inc. for returns at 1-800-288-0741 Monday – Friday 8:30 am to 5 pm Central Time or recall@mwcleaningsolutions.com.

Consumers with questions regarding this recall can contact Jarman’s Midwest Cleaning System’s Inc. at recall@mwcleaningsolutions.com or 1-800-288-0741 Monday – Friday 8:30 am to 5 pm Central Time. Consumers should contact their healthcare provider if they have experienced any health concerns that may be related to using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Jarman’s Midwest Cleaning System’s Inc.

Today's Weather Outlook for the Corridor

Today's weather forecast and a four day outlook.  Check this page for the latest weather reports in the corridor area.  Up-to-date weather conditions for the Iowa City area are observed at the Iowa City, Iowa City Municipal Airport, IA.  For weather conditions specific to other cities outside the corridor area, just type in your zip code below.

Coralville, Iowa, weather forecast

Type in your zip code for your weatherecast




McDonald's Introducing New Strawberry Shortcake McFlurry in April

Strawberry Shortcake McFlurryInspired by the classic flavors and textures of strawberry shortcake, McDonald's fans can get their hands on the signature creamy vanilla soft serve, strawberry-flavored clusters, and crispy cookies in McFlurry form starting April 3, 2023.

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Reach the corridor audience with a LOCAL search directory.  Get listed in the Coralville Courier search directory.  It's easy, it's direct, it's cost-effective, it's LOCAL and mobile friendly.  And once you're listed, you're always listed.  That's right, no renewals, no sales calls, it's just a one-time $30 set-up fee to get listed forever and take advantage of unlimited updates!  You can change/update/add to your message at any time.   Running a special?  We'll post it.  Holding an event?  We'll post it.  Just want to say you had a great weekend, "Thank you patrons" or "Congratulations Hawkeyes?"  We'll post it!   We promote you online, it's what we do.

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Second Nature Brands Issues Allergy Alert on Undeclared Wheat in Gluten Free Reese’s Pieces Brownie Brittle


Product Type:  Food & Beverages
Reason for Announcement: Undeclared Wheat
Company Name:  Second Nature Brands
Brand Name: Sheila G’s
Product Description: Gluten Free Reese’s Pieces Brownie Brittle

Company Announcement

Reese's Pieces Brownie BrittleSecond Nature Brands of Madison Heights, MI, is recalling its 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle because they may contain undeclared wheat.

People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Gluten Free Reese’s Pieces Brownie Brittle were distributed nationwide in retail stores and through online orders.

The product comes in a 4-ounce pouch UPC 711747011562 marked with lot codes SG 1054 15/NOV/2023 1S and SG 1054 15/NOV/2023 2S on the backside of pouch.

One illness has been reported to date in connection with this problem, to date.

The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates the problem was caused by cross-contamination at a co-manufacturer, resulting in undeclared wheat in the product.

Production of the product has been suspended until FDA and the company are certain that the problem has been corrected.

Consumers who have purchased 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle with lot codes SG 1054 15/NOV/2023 1S and SG 1054 15/NOV/2023 2S should not consume the product and should contact Brownie Brittle for a full refund.

Consumers may contact the company by calling at (800) 651-7263 Monday-Friday from 8:30AM - 5:00PM EST or via email at recall@browniebrittle.com Second Nature Brands is conducting this recall with the full knowledge and cooperation of the U.S. Food and Drug Administration.

Company Contact Information

Second Nature Brands
(800) 651-7263
Matt Friedman
(248) 762-1430

Pretzelmaker® Opens First Drive-Thru Location in Iowa with Fresh Twist Concept

Pretzel Franchise Delivers All-Day Menu Options to Mason City

PretzelmakerLOS ANGELES -- Pretzelmaker, home of the Original Pretzel Bites, has officially rolled into its first drive-thru location in Mason City, IA with its Fresh Twist brand in partnership with franchisee, Mark Frandle. Along with a drive-thru, guests can also visit the pick-up window for craveable menu items all day long, including fresh-baked Pretzel Bites, breakfast sandwiches on pretzel rolls, Pretzel Flatbread Pizzas, and specialty coffee beverages.

Pretzelmaker launched the Fresh Twist brand back in 2018 to fulfill a growing demand for breakfast and late-night options. The portability of the menu items pairs well with drive-thru models in addition to travel centers, universities, and airports.

“We are thrilled to debut Pretzelmaker’s first drive-thru location to date in Mason City with our franchisee, Mark Frandle, who had the vision to bring this to life in his local community,” said Jenn Johnston, President of FAT Brands’ Quick-Service Division. “Our Fresh Twist model was designed to cater to smaller footprints and on-the-go customers, so we see this opening as a perfect jump-start to fuel additional drive-thru growth in the years to come.”

The Fresh Twist by Pretzelmaker Mason City is located at 1620 S. Federal Avenue, Suite 410, Mason City, IA 5040 and is open Monday through Saturday, 10:00 a.m. to 7:00 p.m., and Sunday, 11:00 a.m. to 5:00 p.m.

For more information on Pretzelmaker, visit www.pretzelmaker.com.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Pretzelmaker ®

Since 1991, Pretzelmaker® has specialized in serving fresh baked, hand-rolled soft pretzel products, dipping sauces, and beverages. Long recognized as an innovator in their industry, the brand is credited with inventing the popular Pretzel Dog, Mini Pretzel Dogs, and the portable Pretzel Bites. Following integration in 2010, the Pretzelmaker® brand now also includes Pretzel Time®. Pretzelmaker® is currently the second largest soft pretzel concept in the United States and is also expanding worldwide with locations in Canada, Guam, Saudi Arabia, and Mexico. Pretzelmaker has recently introduced a new twist to the brand, the Fresh Twist by Pretzelmaker® concept. The menu offers breakfast sandwiches on pretzel buns, Cinnamon Toast Pretzel Sticks, Pretzel Flatbread Pizzas, and Pepperoni Pretzel Rolls in addition to its fresh hand-rolled Pretzels, Pretzel Bites, Pretzel Dogs and all-natural lemonades and smoothies. For more information, visit www.pretzelmaker.com.

Veridian Credit Union seeks candidates for new associate director program

Veridian Credit UnionWATERLOO, Iowa – Veridian is seeking candidates for its new associate director program. As a not-for-profit cooperative, Veridian members democratically elect directors to serve on its board and set the credit union’s strategic direction. The new associate director program is designed to provide education and development for those interested in eventually joining Veridian’s board as a director.  Applications are available at veridiancu.org/elections and due Wednesday, April 19 by 5:00 p.m. Veridian members will vote from June 14 through July 13 to elect three associate directors. Election results will be announced at Veridian’s virtual Annual Meeting on Tuesday, July 18 at 5:00 p.m.

“The democratic election of our board is fundamental to the credit union difference and ensures that decisions at the highest level of our credit union are made in the best interest of our members,” said Veridian CEO Renee Christoffer. “The associate director program will allow us to provide an additional layer of education, support and experience while bringing our newest elected leaders on board.”

Associate directors will be elected to staggered terms and work with directors to collaborate in strategic planning, determine policy, attend regular meetings, act as an ambassador of the credit union, and meet ongoing professional development and educational requirements. The duties of an associate director on Veridian’s board are the same as that of a director, with the exception of voting in board meetings.

Eligible candidates must be a Veridian member, primary account holder in good standing and age 18 or older, among other eligibility requirements. Details and the candidate application are available at veridiancu.org/election.

Veridian Credit Union, founded in 1934 in Waterloo, Iowa, is a not-for-profit financial cooperative owned by its members. The credit union offers a full range of business and consumer financial services with 1,000 employees and 30 branches across Iowa and eastern Nebraska. For more information, visit veridiancu.org or call (800) 235-3228.

Scooter’s Coffee® Presents $68,324 Check Donation to Big Brothers Big Sisters of America

Customers Support the Youth Mentorship in Celebration of Scooter’s® 25th Birthday

Scooter's Coffee and Big Brothers Big Sisters of the Midlands - Omaha  Neb.OMAHA, Neb., – Through the generosity of its customers, employees and franchisees, Scooter’s Coffee is proud to support the country’s largest youth mentoring organization through a $68,324 check donation. Scooter’s Coffee presented the donation to Big Brothers Big Sisters of America at its annual GROW Conference in Omaha, Nebraska on March 23, Scooter’s Coffee’s 25th Birthday.

In celebration of its 25th Birthday, Scooter’s Coffee partnered with Big Brothers Big Sisters of America to support its mission of helping young people realize their full potential through the power of mentorship. Big Brothers Big Sisters reaches youth in 5000+ communities nationwide through its network of over 230 local agencies.

During the week of February 26, customers had the opportunity to purchase a Scooter’s Coffee Birthday Cake Latte and Birthday Cake Bite – with a portion of proceeds benefiting Big Brothers Big Sisters of America. More than 68,800 birthday treats were purchased across Scooter’s footprint. The $68,324 donation will support Big Brothers Big Sisters’ mentoring efforts in hometowns where customers purchased a birthday treat or added a donation to their order.

“We’re thrilled to partner with Scooter’s Coffee and empower more young people nationwide to reach their full potential through transformative mentorship opportunities,” said Deborah Barge, Chief Development Officer at Big Brothers Big Sisters of America. “This generous donation will build the impactful connections and communities that ignite the power and promise of youth.”

“Many of the friendly Scooter’s Coffee baristas are teenagers experiencing their first job,” said Scooter’s Coffee, LLC President Joe Thornton. “Our franchisees and store teams take great care to develop skills that will serve them well in life, so we are very passionate about supporting the mission of Big Brothers Big Sisters of America. It helps youth in a myriad of ways, including instilling more confidence to help them thrive.”

About Scooter’s Coffee
Founded in 1998 by Don and Linda Eckles in Bellevue, Nebraska, Scooter’s Coffee uses only the finest coffee beans in the world, which are roasted by its affiliated company, Harvest Roasting, in Omaha, Nebraska. In more than two decades of business, the key to Scooter’s Coffee’s success is simple: stay committed to the original business principles and company’s four core values, which are Integrity, Love, Humility and Courage. The Scooter’s Coffee Brand Promise, often recited to franchisees, customers and employees, is: “Amazing People, Amazing Drinks… Amazingly Fast!®” It represents the company’s business origins and reflects a steady commitment to providing an unforgettable experience to loyal and new customers.

Scooter’s Coffee, which is celebrating its 25th anniversary in 2023, is at the dawn of a strategic growth phase nationwide, approaching 700 stores in 29 states. The U.S. coffee market is an estimated $48 billion-a-year, recession-resistant industry, and Scooter’s Coffee is striving to become the #1 drive-thru specialty coffee franchise system in the nation.

For more information, visit scooterscoffee.com, facebook.com/scooterscoffee, or ownascooters.com, or call 877-494-7004.

About Big Brothers Big Sisters of America
Founded in 1904, Big Brothers Big Sisters of America is the largest and most experienced youth mentoring organization in the United States. The mission of Big Brothers Big Sisters of America is to create and support one-to-one mentoring relationships that ignite the power and promise of youth. Big Brothers Big Sisters' evidence-based approach is designed to create positive youth outcomes, including educational success, avoidance of risky behaviors, higher aspirations, greater confidence, and improved relationships. Big Brothers Big Sisters has over 230 local agencies serving more than 5,000 communities across all 50 states. For more information, visit: http://www.bigbrothersbigsisters.org