Eton Pharmaceuticals and ANI Pharmaceuticals Announce Commercial Availability of Carglumic Acid Tablets, the First and Only FDA-Approved Generic Version of Carbaglu® (carglumic acid)
- Product is now available exclusively through Anovo specialty pharmacy
- Product is stable at room temperature while Carbaglu® requires refrigeration
Eton Cares patient support program will offer$0 co-pays to commercial insurance patients
The product will be marketed by
“We are excited to offer patients a convenient Carglumic Acid product that does not require refrigeration and to provide it at a lower price than the existing Carbaglu®. We believe the adoption of our product will result in significant financial savings to the
The product application was granted Competitive Generic Therapy (CGT) designation by the FDA, and as a result, the product is expected to receive 180 days of generic exclusivity. “This approval further strengthens ANI’s focus on niche opportunities and maintains our leadership position in Competitive Generic Therapy approvals,” said
Carglumic Acid tablets are available exclusively through Anovo, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. Anovo will administer the Eton Cares Program in partnership with
Clinicians seeking to prescribe Carglumic Acid tablets can e-prescribe by selecting Anovo #5 or fax in a patient referral form. Additional product details can be found on the product website, www.carglumicacid.com.
For questions regarding prescription fulfillment, please contact Anovo at 1-888-991-1330.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Carglumic Acid?
- Carglumic Acid tablets are for oral suspension and must be mixed in water before taking. Carglumic Acid should not be mixed in any food or liquid other than water.
- Do not swallow Carglumic Acid tablets whole.
- Do not crush Carglumic Acid tablets.
- Take Carglumic Acid right before meals or feedings.
What are the possible side effects of Carglumic Acid?
- The most common side effects of Carglumic Acid include vomiting, abdominal pain, fever, tonsillitis, anemia, diarrhea, ear infection, infections, inflammation of the throat and nasal passages, decreased hemoglobin in the red blood cells, and headache.
- This is not a complete list of all possible side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.
Please visit www.carglumicacid.com for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see the Full Prescribing Information, including Instructions for Use, for Carglumic Acid.
USE
- Carglumic Acid is for pediatric and adult patients as supplemental therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
- Carglumic Acid is for pediatric and adult patients as maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
Carbaglu® is a registered trademark of
About
About
Eton’s Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing, and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the
ANI’s Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the development, manufacturing and commercialization of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the
Eton Contact:
dkrempa@etonpharma.com
612-387-3740
ANI Media Contact:
ASalerno-Robin@dna-comms.com
212-445-8219
Source: Eton Pharmaceuticals