Full Press Release Details
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 |
PARK, Ill., Dec. 20, 2021 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused
on developing and commercializing treatments for rare diseases and ANI Pharmaceuticals, Inc (Nasdaq: ANIP), a bio-pharmaceutical company
serving patients in need through the development and manufacturing of high-quality generic and branded medicines, today announced the
commercial launch of Carglumic Acid tablets.
product will be marketed by Eton Pharmaceuticals and is the first and only FDA-approved generic version of Carbaglu .
It was approved by the FDA for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
The product is AB-rated and is bioequivalent and therapeutically equivalent to Carbaglu , which allows pharmacies to substitute
it in place of Carbaglu prescriptions. The product application is owned by Novitium Pharmaceuticals, a subsidiary of
ANI Pharmaceuticals.
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
U.S. healthcare system and to many patients through lower co-pay and co-insurance costs," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
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 Nikhil Lalwani, CEO Of ANI Pharmaceuticals.
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 Eton Pharmaceuticals. The program will provide prescription fulfillment,
insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services
designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients.
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.
questions regarding prescription fulfillment, please contact Anovo at 1-888-991-1330.
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. |
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. |
visit www.carglumicacid.com for more information.
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.
see the Full Prescribing Information, including Instructions for Use, for Carglumic Acid.
| 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. |
is a registered trademark of Recordati Rare Disease Inc.
Eton Pharmaceuticals
Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE , Carglumic
Acid, Biorphen , Alaway Preservative Free, Rezipres , and Eprontia , and has four
additional products that have been submitted to the FDA.
Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high
quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information,
please visit www.anipharmaceuticals.com.
Forward-Looking 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 Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of
the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances
that exist after the date on which they were made.
Forward-Looking Statements
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.
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 U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory
and other approvals and marketing.
detailed information on these and additional factors that could affect the Company's actual results are described in the Company's
filings with the Securities and Exchange Commission ("SEC"), including its most recent annual report on Form 10-K and quarterly
reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the
date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes
no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.