NDA 21695, held by Lupin. Fenofibrate.
As of Nov 15, 2026, NDA 21695 (Antara (Micronized)), held by Lupin, was first approved by FDA on Nov 30, 2004, with 17 approved supplements and 0 published complete response letters.
Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined.
| Oct 21, 2005 | Supplement 1Efficacy (new indication or use) | Approved | |
| Nov 30, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Antara (Micronized)43MG · capsule;oral | Fenofibrate | RxReference drug |
| Antara (Micronized)87MG · capsule;oral | Fenofibrate | Discontinued |
| Antara (Micronized)130MG · capsule;oral | Fenofibrate | RxReference drug |
| Antara (Micronized)30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fenofibrate | DiscontinuedReference drug |
| Antara (Micronized)90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Fenofibrate | DiscontinuedReference drug |
| Oct 1, 2025 | Supplement 29Labeling · Standard review | Approved | |
| Jul 30, 2024 | Supplement 28Labeling · Standard review | Approved | |
| Jun 3, 2021 | Supplement 22Labeling | Approved | |
| May 15, 2019 | Supplement 20Labeling | Approved | |
| Feb 4, 2019 | Supplement 18Manufacturing · Standard review | Approved | |
| Nov 7, 2018 | Supplement 19Labeling · Standard review | Approved | |
| May 18, 2018 | Supplement 17Labeling | Approved | |
| Sep 11, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Nov 29, 2016 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 31, 2015 | Supplement 12Manufacturing · Standard review | Approved | |
| Sep 4, 2014 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | Supplement 9Manufacturing · Standard review | Approved | |
| Dec 19, 2012 | Supplement 10Labeling · Standard review | Approved | |
| Mar 1, 2012 | Supplement 8Labeling · Standard review | Approved | |
| Jun 3, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Oct 21, 2005 | Supplement 1Efficacy (new indication or use) | Approved | |
| Nov 30, 2004 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
