When was entacapone FDA approved?

When was entacapone FDA approved?

Approval Date: 12/30/1999.

What drugs are regulated by the FDA?

prescription drugs (both brand-name and generic) non-prescription (over-the-counter) drugs….Biologics, including:

  • vaccines for humans.
  • blood and blood products.
  • cellular and gene therapy products.
  • tissue and tissue products.
  • allergenics.

What is the brand name for entacapone?

BRAND NAME(S): Comtan. USES: This medication is used with other medications (levodopa/carbidopa) to treat Parkinson’s disease. Entacapone belongs to a class of drugs known as COMT inhibitors.

Does the FDA regulate medicines?

The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. Once a drug is on the market, FDA continues its oversight of drug safety and effectiveness.

What is the pharmacologic action of entacapone?

Entacapone blocks a certain natural substance (COMT enzyme) that breaks down the levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn’t wear off before the next dose.

What is not regulated by the FDA?

Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices. Unlike animal drugs, animal devices do not have to be approved by FDA before they can be marketed.

Why is entacapone prescribed?

Entacapone is used together with carbidopa and levodopa to treat “wearing-off” symptoms of Parkinson’s disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

What are FDA guidelines?

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.

How do you know if an item is FDA approved?

How can I find out if my medicine is approved by FDA? To find out if your drug has been approved by FDA, use [email protected], a catalog of FDA-approved drug products, as well as drug labeling. [email protected] contains most of the drug products approved since 1939.

What are the contraindications for entacapone?

Entacapone tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Monoamine oxidase (MAO) and COMT are the two major enzyme systems involved in the metabolism of catecholamines.

How much entacapone can you take in a day?

The recommended dose of Entacapone is one 200 mg tablet administered concomitantly with each levodopa and carbidopa dose to a maximum of 8 times daily (200 mg x 8 = 1,600 mg per day). Clinical experience with daily doses above 1,600 mg is limited.

What is entacapone tablets USP?

Entacapone tablets USP is available as tablets containing 200 mg Entacapone. Entacapone is an inhibitor of catechol- O-methyltransferase (COMT), used in the treatment of Parkinson’s disease as an adjunct to levodopa and carbidopa therapy.

What happens when entacapone and carbidopa are taken together?

When 200 mg Entacapone is administered together with levodopa and carbidopa, it increases the area under the curve (AUC) of levodopa by approximately 35% and the elimination half-life of levodopa is prolonged from 1.3 hours to 2.4 hours.