Mumbai: Cipla, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride Injection USP, 0.2mg/mL, single-usesterile Ampoule from the United States Food and Drug Administration (US FDA).
Cipla’s Isoproterenol Hydrochloride Injection USP, 0.2mg/mL, ampoule is APrated generic therapeutic equivalent version of Hospira Inc’s Isuprel Injection, 0.2mg/ml, Cipla said in a filing with BSE.
Isoproterenol Hydrochloride are indicated for the treatment of Mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
It is also used As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.
According to IQVIA (IMS Health), Isuprel Injection and its generic equivalents had US sales of approximately USD 148M for the 12-month period ending April 2018, the filing added.