FDA Approved Biologics List And Medical Conditions That They Treat | Joseph Han, PharmD Intern | RxEconsult

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List Of FDA Approved Biologic Medications And Medical Conditions That They Treat Category: Rheumatoid Arthritis & Inflammatory Conditions by - January 23, 2017 | Views: 131812 | Likes: 0 | Comment: 1  


list of FDA approved biologics

What are Biologic Drugs?

According to the FDA, biologic drugs include:

  • vaccines
  • blood and blood components
  • allergenics
  • somatic cells
  • gene therapy
  • tissues
  • recombinant therapeutic proteins 

Biologics may contain sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells and tissues. Biologics are produced from human, animal, or microorganism by using modern biotechnology techniques and other advanced technologies. Gene-based and cellular biologics are the most advanced medicines that are used to alleviate and often cure medical conditions that used to be untreatable.

How are biological drugs different from other drugs?

Biologics are more complex than drugs that are chemically produced in a laboratory and they tend to be heat sensitive and susceptible to contamination because they contain proteins and other components of living material. Most biologic drugs are administered by injection because they are not available as tablets. The most important aspect of biologic drugs is that they are often the best option for treating and curing medical illnesses and conditions (including inheritable conditions) that have no other treatments.

Here is a list of FDA-approved biologics for the following medical conditons:

  • cardiovascular disease 
  • neuroloical
  • autoimune diseases
  • dermatology
  • eye conditions
  • cancer
  • metabolic conditions
  • infections
  • transplant
  • hematology
  • antidotes
  • respiratory conditions

Cardiovascular Disease

Fibrinolytic therapy (also known as clot busters) are used for opening clogged blood vessels in patients who are being treated for an acute heart attack. Anticoagulants are used to prevent blood clots in blood vessels or a stent in people undergoing percutaneous coronary intervention (PCI) to increase blood flow in clogged artery.

Biologic Medications for Cardiovascular Conditions:

Myocardial ischemia

  • abciximab (ReoPro)

Myocardial infarction

  • alteplase (Cathflo Activase, Activase) 
  • reteplase (Retavase)
  • tenecteplase (TNKase)

Next: Biologics for Neurological, Dermatology, Eye Conditions

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