Treats central precocious puberty (CPP) (gonadotropin-dependent precocious puberty). NDA 19886, held by Pfizer. Nafarelin Acetate.
As of Nov 13, 2026, NDA 19886 (Synarel), held by Pfizer, was first approved by FDA on Feb 13, 1990, with 27 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH.
| Dec 24, 1998 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 1990 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| SynarelEQ 0.2MG BASE/SPRAY · spray, metered;nasal | Nafarelin Acetate | RxReference drug |
| Nov 24, 2025 | Supplement 40Labeling · Standard review | Approved | |
| Jan 31, 2023 | Supplement 39Labeling · Standard review | Approved | |
| Apr 22, 2022 | Supplement 38Labeling · Standard review | Approved | |
| May 19, 2017 | Supplement 35Labeling · Standard review | Approved | |
| May 19, 2017 | Supplement 33Labeling · Standard review | Approved | |
| Aug 8, 2015 | Supplement 32Labeling · Standard review | Approved | |
| Mar 25, 2014 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jan 11, 2012 | Supplement 30Labeling | Approved | |
| Jan 4, 2011 | Supplement 27Labeling · Standard review | Approved | |
| Jan 4, 2011 | Supplement 26Labeling | Approved | |
| Apr 12, 2006 | Supplement 22Labeling · Standard review | Approved | |
| Jun 28, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 29, 2001 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 6, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 6, 1999 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1999 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Dec 24, 1998 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 7, 1995 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 29, 1995 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1994 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 28, 1991 | Supplement 6Labeling | Approved | None posted |
| Aug 1, 1991 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1991 | Supplement 4Labeling | Approved | None posted |
| Mar 25, 1991 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1991 | Supplement 2Labeling | Approved | None posted |
| Mar 16, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1990 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
