Granules India gets USFDA’s nod for hypertension generic

Granules India gets USFDA’s nod for hypertension generic

Subject: Science and Tech

Section: Health

More about the news:

• Granules India received USFDA approval for its new generic drug, equivalent to Losartan Potassium and Hydrochlorothiazide Tablets.
•  It treats hypertension and stroke risk reduction, with an annual US market value of around $73 million.
•  This marks Granules’ 60th ANDA approval, including 58 final and 2 tentative approvals from the USFDA.

What is Generic Drug:

• It is a medication that has exactly the same active ingredient as the brand-name drug and yields the same therapeutic effect.
• It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used.
• These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.
• They also have the same risks and benefits as their brand-name counterparts.
• Generic drugs do not need to contain the same inactive ingredients as the brand-name product.
• A generic drug can only be marketed after the brand name drug’s patent has expired.
• Generic drugs are usually much less expensive than brand-name drugs.

What is US FDA:

• The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services.
• FDA is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.
• The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs , vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feeds and veterinary products.
• The FDA gives approval to regulated products before they can be sold in the U.S.
• FDA has the power to recall products on the market, if necessary, for safety and other reasons.
• The FDA is known for its work in regulating the development of new drugs. The FDA has developed rules regarding the clinical trials that must be done on all new medications. Pharmaceutical companies must test drugs through four phases of clinical trials before they can be marketed to individuals.
• The FDA approves products in the biotech and pharmaceutical industries, and its approval or rejection of a product can have a financial impact.
• The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services.
• The FDA has its headquarters in unincorporated White Oak, Maryland.