NDA 20615, held by Mylan Institutional. Clonidine Hydrochloride.
As of Nov 14, 2026, NDA 20615 (Duraclon), held by Mylan Institutional, was first approved by FDA on Oct 2, 1996, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 1996 | Original applicationNew dosage form · Standard review | Approved |
| Duraclon1MG/10ML (0.1MG/ML) · injectable;injection | Clonidine Hydrochloride | RxReference drug |
| Duraclon5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Clonidine Hydrochloride | DiscontinuedReference drug |
| Aug 1, 2016 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 11, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2010 | Supplement 3Labeling · Standard review | Approved | |
| Apr 24, 2009 | Supplement 2Labeling · Standard review | Approved | |
| Apr 27, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1996 | 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
