Pharmaceutical company Cipla Limited (BSE:500087) (NSE:CIPLA EQ) reported on Monday the receipt of the final approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3ml from the US Food and Drug Administration (FDA).
According to the company, the Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
The Icatibant Injectable pre-filled syringe in 30mg/3ml is an AP-rated generic version of Shire's Firazyr.
For the 12-month period ending May 2020, Firazyr and its generic equivalents had US sales of approximately USD270m based on data from IQVIA (IMS Health).
Teva and Takeda change focus of joint business venture in Japan
Endo International names new non-executive director
The FDA provides update of COVID-19
US FDA Approves Abbreviated NDA for Heparin Sodium
Cipla receives US FDA approval for Icatibant Injectable 30mg/3mL
Cipla wins final approval from FDA for generic Firazyr
Amneal unveils FDA approved generic fluphenazine for treating schizophrenia
Amneal Launches Generic Fluphenazine Following ANDA Approval by FDA
US FDA approves Mylan and Fujifilm Kyowa Kirin Biologics' Hulio
CEBINA identifies antihistamine nasal spray Azelastine as potential anti-COVID-19 approach