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`Slayback Pharma announces approval of Icatibant Injection 30 mg/3 ml (10 mg/ ml), generic equivalent of Firazyr®.
`
`Slayback Pharma announces
`approval of Icatibant Injection
`30 mg/3 ml (10 mg/ ml), generic
`equivalent of Firazyr®.
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`NEWS PROVIDED BY
`Slayback Pharma LLC
`
`Sep 02, 2020, 16:15 ET
`
`PRINCETON, N.J., Sept. 2, 2020 /PRNewswire/ -- Slayback Pharma, LLC
`announced today that it has received nal approval for its ANDA for
`Icatibant Injection 30 mg/3 ml (10 mg/ml) in a Pre lled Syringe - a generic
`equivalent of Firazyr®.
`
`Ajay Singh, CEO of Slayback Pharma, said: “We are pleased to announce the
`approval of our ANDA for Icatibant - another complex generic injectable of
`a dif cult-to-characterize peptide and a drug-device combination. We are
`particularly excited at the opportunity to enhance the affordability of yet
`another expensive orphan drug.”
`
`See the following important safety information and refer to the package
`insert for full prescribing information.
`
`Indication
`
`Icatibant injection is indicated for the treatment of acute attacks of
`hereditary angioedema (HAE) in adults 18 years of age and older.
`
`Important Safety Information for Icatibant
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-approval-of-icatibant-injection-30-mg3-ml-10-mg-ml-generic-equivalent-of-fir… 1/3
`
`Eye Therapies Exhibit 2128, 1 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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`7/8/22, 9:57 AM
`
`Slayback Pharma announces approval of Icatibant Injection 30 mg/3 ml (10 mg/ ml), generic equivalent of Firazyr®.
`Angioedema (which can include swelling of the throat or larynx) can be
`life-threatening. Inject Icatibant and go to the nearest hospital
`emergency room immediately if you have a laryngeal attack.
`
`Do not take Icatibant if you are allergic to it or any other ingredient in
`the formulation.
`Do not administer if the product contains visible particulate material
`or is discolored.
`Do not take more than 3 doses in 24 hours.
`Do not drive or use machinery if you feel dizzy, drowsy, or tired.
`Use only the needle that is provided with the syringe.
`Please discuss with your doctor if you:
`are taking any blood pressure medications
`have hepatic or renal disease
`are pregnant, nursing, or planning on being pregnant or nursing
`are under the age of 18
`recently experienced a heart attack, unstable angina, or a stroke
`have any other medical conditions
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`Some known side effects are:
`redness, bruising, swelling, warmth, burning, itching, irritation,
`hives, numbness, pressure, or pain at the injection site
`dizziness
`drowsiness
`fever
`headache
`increase in transaminase (liver enzyme) levels
`nausea
`rash
`tiredness
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`These are not all the possible side effects of Icatibant. Tell your healthcare
`provider if you have any side effect that bothers you or that does not go
`away.
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`Tell your healthcare provider if you have any other medical conditions. You
`and your healthcare provider will decide if Icatibant is right for you.
`
`For more information, please see full Prescribing Information.
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-approval-of-icatibant-injection-30-mg3-ml-10-mg-ml-generic-equivalent-of-fir… 2/3
`
`Eye Therapies Exhibit 2128, 2 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`7/8/22, 9:57 AM
`
`Slayback Pharma announces approval of Icatibant Injection 30 mg/3 ml (10 mg/ ml), generic equivalent of Firazyr®.
`You are encouraged to report any side effects or adverse event by calling
`1-844-566-2505 or emailing medical@slayback-pharma.com. If you
`prefer, you may contact the U.S. Food and Drug Administration (FDA)
`directly at fda.gov/medwatch or call 1-800-FDA-1088.
`
`Slayback Pharma is a New Jersey-based pharmaceutical company focused
`on the development of complex and specialty generic products.
`
`Intended only for residents of the United States of America.
`© 2020 Slayback Pharma, Princeton, NJ 08540
`
`References:
`Icatibant Injection prescribing information. Slayback Pharma, 6/2020
`Firazyr® is a registered trademark of Shire, a Takeda company.
`
`SOURCE Slayback Pharma LLC
`
`Related Links
`http://www.slayback-pharma.com
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-approval-of-icatibant-injection-30-mg3-ml-10-mg-ml-generic-equivalent-of-fir… 3/3
`
`Eye Therapies Exhibit 2128, 3 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
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