Milestones

Company History

Cumberland Pharmaceuticals is dedicated to improving the quality of patient care through the delivery of FDA-approved, high-quality innovative products.

We continue to expand our reach by forging partnerships both domestically and around the globe as a publicly traded company.  

In March, our CEO A.J. Kazimi was named to Nashville Post’s 2024 In Charge – Health Care list for the sixth year.

In November, Cumberland received FDA orphan drug and rare pediatric disease designations for our new treatment of Duchenne Muscular Dystrophy.

In December, the FDA approved a supplemental New Drug Application (sNDA) for our Acetadote® (N-acetylcysteine for injection) product. The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion. This streamlined administration can improve patient outcomes and reduce the risk of adverse events.

In May, the FDA approved expanded labeling for Caldolor®, our
intravenously delivered formulation of ibuprofen, to include use in infants.
The non-narcotic agent may now be administered for the treatment of pain
and fever in patients 3 to 6 months of age.

 

In June, we expanded our oncology sales division to deliver our newest
brand Sancuso® – to help cancer patients tolerate their chemotherapy
treatments. Sancuso is the first and only FDA-approved prescription patch
for the prevention of nausea and vomiting in patients receiving certain
types of chemotherapy.

 

Additionally, the FDA cleared our Investigational New Drug Application
(IND) for a Phase II study in patients with Idiopathic Pulmonary Fibrosis,
the most common form of progressive fibrosing interstitial lung disease.

In January, Cumberland launched Sancuso®, the first and only FDA
 approved prescription patch for the prevention of nausea and vomiting in
 patients receiving certain types of chemotherapy treatment. To support
 Sancuso, we established a dedicated oncology sales division,
 Cumberland Oncology.

 

In March, we entered into a new agreement for Vibativ® in the Middle East
 and established distribution for the Vibativ product there, through a
 partnership with Tabuk Pharmaceutical Manufacturing Company. Tabuk
 will introduce the product in Saudi Arabia, Jordan, and potentially other
 countries in the Middle East.

 

In October, we announced a new partnership in Mexico with PiSa
 Pharmaceutical for the registration and commercialization of Caldolor®.
 Caldolor is our non-narcotic pain relief product that can also considerably
 reduce the need for post-operative opioids and potential for opioid
 addiction.

 

In November, Cumberland opened new headquarters at the Broadwest
 campus in the Vanderbilt West End corridor of Nashville. The move allows
 the Company to accommodate growth, support our team and better serve
 our international base of customers and partners.

In 2021, we supported our partner SciClone Pharmaceuticals in their
 submission of Vibativ®, our potent antibiotic, for approval in China.

 

In November, Cumberland announced that Caldolor® is now FDA
 approved for pre-operative administration.

 

In December, Cumberland acquired Sancuso®, the first and only FDA
 approved prescription patch that prevents nausea and vomiting in patients
 receiving certain types of chemotherapy treatment.

In January, Cumberland launched our next generation Caldolor® product
 featuring a ready-to-use formulation in a pre-mixed bag.

 

In February, our CEO A.J. Kazimi was named a Nashville Business
 Journal Health Care Awards winner for the third consecutive year.

 

Throughout the year, we also launched several national initiatives to help
 hospitals access our acute care brands during the pandemic. Our Vibativ®
 product was used to help COVID-19 patients who developed bacterial
 infections in their lungs.

In 2019, Cumberland received FDA Orphan Drug Grant funding and initiated a clinical program to study ifetroban in patients with Duchenne Muscular Dystrophy.

Additionally, Cumberland Pharmaceuticals Inc. announced it entered into an exclusive agreement with China’s Winhealth Pharma Group for the licensing rights of Acetadote®, which is used to prevent or reduce liver damage resulting from acetaminophen overdose, and Caldolor®, which is used to treat pain and fever in the hospital setting. The agreement provided Winhealth licensing rights to commercialize both FDA-approved drugs in China, the second largest market for pharmaceuticals in the world after the U.S.

In May, our CEO A.J. Kazimi was named a Nashville Business Journal Health Care Awards winner.

We also obtained FDA approval for the next generation Caldolor® product featuring a new patented formulation and improved packaging.

In January, we launched the Cumberland Pharma Foundation to organize and facilitate our ongoing philanthropic endeavors for various not-for-profit organizations whose activities align with Cumberland’s mission.

In May, our CEO A.J. Kazimi was named a Nashville Business Journal Health Care Awards winner.

In November, Cumberland acquired and launched Vibativ® (telavancin), an injection used for the treatment of certain serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

In 2017, we signed and fully implemented a new co-promotion arrangement with Poly Pharmaceuticals, Inc. They’re a privately held U.S. specialty pharmaceutical company that began introducing Kristalose® to medical specialties we don’t cover.

In December, the Nashville Business Journal featured Cumberland as the fastest growing Nashville health care company of 2017.

Cumberland announced a new development program to develop
 Vasculan® oral capsule for the treatment of systemic sclerosis.

Cumberland announced FDA approval of our Caldolor® (ibuprofen)
 injection for pediatric patients 6 months of age and older.

 

Additionally, our Caldolor® product was launched in Australia.

Cumberland announced the acquisition and launch of our
 Vaprisol® product, indicated for the treatment of hyponatremia.

Cumberland received FDA approval for updated labeling for Acetadote®.
 The new labeling revised the product’s indication to offer new dosing
 guidance for specific patient populations.

In August, Cumberland was named to Modern Healthcare’s
 inaugural Healthcare’s Hottest List honoring health care’s 40 fastest
 growing health care companies.

 

We were also named as a finalist in the Nashville Business Journal’s Best
 in Business awards.

In January, we launched our next generation Acetadote® product.

 

Cumberland was also named one of the fastest growing companies in
 North America on Deloitte's 2011 Technology Fast 500™ list for the
 second consecutive year.

 

In November, we acquired the FDA registration and trademark for
 Kristalose®.

In 2010, Cumberland’s CEO A.J. Kazimi was named a finalist for Ernst & Young’s Entrepreneur Of The Year® award in Alabama/Georgia/Tennessee.

Cumberland was also recognized as a finalist in the Nashville Business Journal’s Best in Business competition.

Additionally, we announced the availability of Acetadote® in Australia, marking the first launch of a Cumberland product outside of the United States.

In 2009, Cumberland received FDA approval for and launched
 Caldolor®, the first injectable treatment for pain and fever approved in the
 U.S.

 

In August, we signed an agreement with DB Pharm, our partner in South
 Korea, for the registration and commercialization of Caldolor® there.

 

We also completed our Initial Public Offering and share listing on the
 Nasdaq exchange.

In 2006, Cumberland was named to the Inc. 500 list of America’s fastest
growing private companies.

 

We also received FDA approval for Acetadote pediatric indication.

 

Additionally, Cumberland acquired commercial rights to Kristalose® and
launched a co-promotion of the brand, the only prescription laxative
product available in a powder formulation for the treatment of acute and
chronic constipation

Cumberland was named to Business Tennessee magazine’s Fast 50 list for a second year in a row.

Cumberland was also honored with a Music City Future 50 Award, which recognizes the region’s most successful private companies.

Cumberland was recognized as one of Business Tennessee magazine’s 50 fastest growing private companies.

In June,  we launched our first FDA-approved product, Acetadote®, for the treatment for acetaminophen overdose.

Cumberland Pharmaceuticals was founded in Nashville, Tennessee.