Slayback Pharma announces approval and launch of Icatibant Injection 30 mg/3 ml (10 mg/ ml), generic equivalent of Firazyr®.
PRINCETON, N.J., Sept. 2, 2020 /PRNewswire/ -- Slayback Pharma , LLC announced today that it has received final approval for Icatibant Injection 30 mg/3 ml (10 mg/ml) in a Prefilled Syringe - a generic equivalent of Firazyr.
Ajay Singh, CEO of Slayback Pharma, said: "The approval of Icatibant, a difficult-to-characterize peptide, in a prefilled syringe injection, is yet another example of Slayback's track record on difficult generics. Our readiness to commence launch immediately upon approval despite the difficulties of the current Covid-19 global lockdown is a testimony to the commitment that our team and our partners have displayed to deliver essential medicines to patients against all odds."
See the following important safety information and refer to the package insert for full prescribing information.
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
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.
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.
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.
You are encouraged to report any side effects or adverse event by calling 1-844-566-2505 or emailing firstname.lastname@example.org. 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.
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SOURCE Slayback Pharma LLC