BVI 1% OVD

by FERRING PHARMACEUTICALS, INC.

On Jul 15, 2014, the FDA received a filing from FERRING PHARMACEUTICALS, INC. for a 30-day notice of process change: packaging. On Aug 12, 2014, the OP review committee issued the following statement with the approval order:

ADDITION OF A NEW AUTOMATED THERMOFORMING MACHINE AND PACKAGING PROCESS.

The review and decision took 28 days.

Trade Name BVI 1% OVD
Generic Name VISCOELASTIC OPTHALMO-SURGICAL AID AGENT
Applicant FERRING PHARMACEUTICALS, INC.
P960011
Contact 100 INTERPACE PARKWAY

PARSIPPANY, NJ, 07054
Product Code LZP

Previous Supplements

SupplementApprovals
S025
May 27, 2014
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
USE OF A NEW INTERMEDIATE VESSEL FOR BVI 1% AND EUFLEXXA OVD.
S024
Dec 10, 2013
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
S023
Jun 04, 2013
ADD A NEW SYRINGE DENESTER MACHINE AND AN ALTERNATIVE ASSEMBLY AND LABELING MACHINE.
S022
Mar 13, 2013
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
CHANGE IN THE CLASSIFICATION OF A MATERIALS WEIGHING ROOM.
S021
Mar 30, 2012
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
ALTERNATE USE OF A NEW SYRINGEABILITY MACHINE FOR QC TESTING.
S020
Jan 27, 2012
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
NEW VISCOMETER, FOR THE IN-PROCESS AND QUALITY CONTROL RELEASE TESTING.
S019
Apr 01, 2011
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
ALTERNATE RHEOMETER FOR TESTING IN-PROCESS CONTROL AND FINISHED PRODUCT SAMPLES.
S018
Mar 08, 2011
LABELING CHANGE - INSTRUCTIONS (SPECIAL(IMMEDIATE TRACK))
APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE. IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE.
S017
Jun 15, 2010
PROCESS CHANGE: STERILIZATION (135 REVIEW TRACK FOR 30-DAY NOTICE)
APPROVAL FOR A CHANGE IN MANUFACTURE USING NEW EQUIPMENT.
S016
Jan 07, 2010
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE.
S015
Jan 07, 2010
CHANGE IN THE LAYOUT OF THE MANUFACTURING FACILITY AND RELOCATION OF THE DISSOLUTION VESSEL AND MICROFILTRATION SYSTEM.
S014
Dec 16, 2009
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
CHANGE IN PRESSURE SET POINTS DURING SODIUM HYALURONATE FERMENTATION.
S013
Feb 29, 2008
PROCESS CHANGE: STERILIZATION (30-DAY NOTICE)
CHANGE IN THE STERILIZATION CYCLE.
S012
Dec 19, 2006
LABELING CHANGE - TRADE NAME (NORMAL 180 DAY TRACK NO USER FEE)
APPROVAL TO CHANGE THE TRADE NAME FROM BIOLON TO BD1% OVD.
S011
Sep 13, 2007
DESIGN CHANGE - MINOR (REAL-TIME PROCESS)
APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
S010
Sep 15, 2005
LABELING CHANGE - TRADE NAME (NORMAL 180 DAY TRACK NO USER FEE)
APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES.
S009
Jan 27, 2005
LOCATION CHANGE: MANUFACTURER (NORMAL 180 DAY TRACK)
APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON.
S008
Apr 01, 2002
LOCATION CHANGE: STERILIZER (NORMAL 180 DAY TRACK)
APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA.
S007
Nov 01, 2002
LOCATION CHANGE: STERILIZER (NORMAL 180 DAY TRACK)
APPROVAL FOR A NEW STERILIZATION FACILITY LOCATED AT MEDIPLAST ISRAEL, LTD., YAVNEM, ISRAEL
S006
Mar 08, 2001
PROCESS CHANGE: MANUFACTURING (135 REVIEW TRACK FOR 30-DAY NOTICE)
APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM).
S005
May 19, 2000
PROCESS CHANGE: STERILIZATION (30-DAY NOTICE)
Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued.
S004
Mar 23, 2001
LOCATION CHANGE: DISTRIBUTOR (NORMAL 180 DAY TRACK)
APPROVAL FOR CIBA VISION TO MARKET BIOLON(TM) 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY IN THE UNITED STATES UNDER THE TRADE NAME "UNIVISC".
S003
Sep 02, 1999
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.
S002
Jul 01, 1999
PROCESS CHANGE: MANUFACTURING (NORMAL 180 DAY TRACK)
Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the BioLon(TM) syringes.
S001
Sep 09, 1998
LOCATION CHANGE: DISTRIBUTOR (NORMAL 180 DAY TRACK)
Approval for Akorn, Inc. to distribute BioLon(TM) in the United States.
Jul 16, 1998
The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.