XERAVA Powder for solution for injection Ref.[10284] Active ingredients: Eravacycline

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

XERAVA contains eravacycline, a synthetic tetracycline-class antibacterial agent for intravenous administration. Chemically, eravacycline is a C7-, C9-substituted sancycline derivative. The chemical name of eravacycline dihydrochloride is [(4S,4aS,5aR,12aS)4(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[2‑(pyrrolidin-1-yl) acetamido]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide] dihydrochloride. The molecular formula for eravacycline dihydrochloride is C27H31FN4O8•2HCl, and its molecular weight is 631.5.

The following represents the chemical structure of eravacycline dihydrochloride:

XERAVA is a sterile, preservative-free, yellow to orange, lyophilized powder in a glass single-dose vial for intravenous infusion after reconstitution and dilution. XERAVA is supplied in two (2) strengths as follows:

  • Each 50 mg single-dose vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0.
  • Each 100 mg single-dose vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride) and the excipient, mannitol (150 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment to 5.5 to 7.0.
Dosage Forms and Strengths

XERAVA for injection is a yellow to orange, sterile, preservative-free, lyophilized powder in single-dose vials for reconstitution and further dilution. XERAVA is available in two strengths:

  • 50 mg of eravacycline (equivalent to 63.5 mg eravacycline dihydrochloride)
  • 100 mg of eravacycline (equivalent to 127 mg eravacycline dihydrochloride)
How Supplied

XERAVA (eravacycline) for injection is a yellow to orange, sterile, preservative-free powder for reconstitution in single-dose 10-mL clear glass vials with a rubber stopper and an aluminum overseal. XERAVA is supplied in the following configurations:

  • XERAVA 50 mg vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride). Each vial is packaged in a single-dose vial carton (NDC 71773-050-05) and supplied in a 12-vial carton containing 12 single-dose vial cartons — NDC 71773-050-12.
  • XERAVA 100 mg vial contains 100 mg of eravacycline (equivalent to 127 mg of eravacycline dihydrochloride). Each vial is packaged in a single-dose vial carton (NDC 71773-100-05) and supplied in shrink wrap packaging, containing 12 single-dose vial cartons — NDC 71773-100-12.

Drugs

Drug Countries
XERAVA Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States
 
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