viernes, 11 de agosto de 2017

FDA Office of Generic Drugs approved first generic for Isuprel (Isoproterenol Hydrochloride) Injection

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On August 2, 2017, the U.S. Food and Drug Administration approved the first generic version of Isuprel.Isoproterenol Hydrochloride Injection received expedited review as a potential first generic. FDA prioritizes the review of potential first generics, which can open the market to competition and drive down prices, in recognition of the fact that drug prices can interfere with patient access to life-saving medications.
Generic drugs approved by FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must also pass the same quality standards as those of brand-name drugs.
Isoproterenol Hydrochloride Injection is indicated:
  • for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy
  • for serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation)
  • for use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available
  • for bronchospasm occurring during anesthesia
  • 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.
The most common side effects reported by people using Isoproterenol Hydrochloride Injection in clinical trials included nervousness, headache, dizziness, nausea, and visual blurring. Cardiovascular side effects reported included tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias (abnormal rhythm of heartbeat originating in the ventricles), and tachyarrhythmias (rapid heartbeat). 
Isoproterenol Hydrochloride Injection should not be used by patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris. Respiratory side effects reported include shortness of breath.  Other reported side effects include flushing of the skin, sweating, mild tremors, weakness, and pallor.
More information on Isoproterenol Hydrochloride Injection may be found within the drug label. Drugs@FDA and Dailymed can be searched for the drug labels of FDA approved drug products.
The full list of first generic drug approvals can be viewed at First Generic Drug Approvals.
Steve L. Morin
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network

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