FDA revokes the ANDAs it granted to Par and ATI.
FDA Revokes the ANDAs It Granted to Par and ATI
WASHINGTON--The Food and Drug Administration, in the first of what may be a series of such moves, has revoked previously sanctioned, abbreviated new drug application approvals granted to Par Pharmaceutical and American Therapeutics Inc., after plant inspections revealed manufacturing problems.
Earlier this month FDA Commissioner Frank Young rescinded approvals on chlorzoxazone, a muscle relaxant patterned after John & Johnson's Parafon Forte. Par received approval to market chlorzoxazone on June 5, and ATI received its approval June 23.
Young has been under pressure from the House energy and commerce subcommittee and from some generics firms to revoke ANDA approvals for firms that have admitted to cheating or making payoffs.
So far as the most recent case is concerned, pressure from the private sector is being brought to bear by Mylan Laboratories of Pittsburgh, Pa., and Barr Laboratories of Pomona, N.Y. Taking a relatively extreme tack, Barr has called for revocation of all Par drug applications since 1986 and of all ATI applications since 1984.
The entire pharmaceutical industry is beginning to feel the adverse effects of this affair.
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|Title Annotation:||Food and Drug Administration revokes abbreviated new drug application approvals; Par Pharmaceutical; American Therapeutics Inc.; Retail Pharmacy|
|Publication:||Chain Drug Review|
|Date:||Aug 28, 1989|
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