BLA 50114, held by Allerquest. Benzylpenicilloyl Polylysine.
As of Nov 14, 2026, BLA 50114 (Pre-Pen), held by Allerquest, was first approved by FDA on Jul 25, 1974, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 1974 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pre-Pen60UMOLAR · injectable;injection | Benzylpenicilloyl Polylysine | Rx |
| Jan 18, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Sep 18, 2009 | Supplement 8Manufacturing | Approved | |
| Apr 6, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1989 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1978 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1976 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1974 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1974 | 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
