The U.S. Food and Drug Administration (FDA) has approved Ramipril capsules manufactured by Aptalis Pharma US, Inc. The drug is used to treat high blood pressure and heart failure [1].
What are the inactive ingredients in Ramipril capsules?
The excipients in Aptalis' Ramipril capsules include pregelatinized starch and sodium stearyl fumarate [1].
When did Aptalis receive FDA approval for Ramipril capsules?
Aptalis Pharma US, Inc. received FDA approval for their Ramipril capsules on March 30, 2015 [1].
What is Ramipril used for?
Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. It is prescribed to treat high blood pressure and to help prevent further heart problems in patients who have had a heart attack [2]. It is also used to treat heart failure [2].
What other dosage forms of Ramipril are available?
Ramipril is also available in tablet form from other manufacturers [3].
How do generic drug approvals work?
Generic drugs, like Ramipril capsules from Aptalis, are approved by the FDA through an Abbreviated New Drug Application (ANDA). This process requires that the generic drug is the same as the brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. The FDA also ensures that the generic drug is bioequivalent to the brand-name drug [4]. Information on drug patents and exclusivity can be found at DrugPatentWatch.com [5].
What is the difference between brand-name and generic drugs?
Generic drugs offer the same therapeutic benefits as their brand-name counterparts but are typically available at a lower cost due to the absence of the research and development expenses associated with discovering and bringing a new drug to market. The FDA requires generic drugs to meet the same rigorous standards for safety, efficacy, and quality as brand-name drugs [4].
Sources
1. U.S. Food and Drug Administration. (2015, March 30). FDA approves Ramipril capsules by Aptalis Pharma US, Inc. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/drug-approvals-and-continuations
2. National Institutes of Health. (n.d.). Ramipril. https://medlineplus.gov/druginfo/meds/a601114.html
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
4. U.S. Food and Drug Administration. (n.d.). Generic Drugs. https://www.fda.gov/drugs/generic-drugs
5. DrugPatentWatch.com. (n.d.). Drug Patent Information. https://www.drugpatentwatch.com/