The FDA issued several approvals in the last week of 1992.
On Thursday, the agency approved marketing of Tilade,nedocromil sodium, a new class of anti-inflammatory drug, forthe preventive management of asthma. Developed by FisonsPharmaceuticals of Ipswich, England, the drug is a non-steroid,inhaled, anti-inflammatory agent.
On Wednesday, SmithKline Beecham announced FDA approvalto market Paxil, paroxetine hydrochloride, a selective serotoninre-uptake inhibitor, for the treatment of depression. That sameday, Astra Pharmaceutical Products Inc., the U.S. subsidiary ofSwedish-based AB Astra, announced FDA approval of EMLACream (2.5 percent lidocaine and 2.5 percent prilocaine), a skinanesthetic that can eliminate the need for needle injectionduring many dermal procedures .
Also last week, Cytogen Corp. (NASDAQ:CYTO) of Princeton, N. J.,announced FDA marketing approval of its monoclonalantibody-based cancer imaging agent OncoScint CR/OV.
On Tuesday, Bristol-Myers Squibb received FDA approval forits Taxol to treat women with advanced ovarian cancer, andGlaxo Holdings won approval of a drug to treat migraineheadache pain.
A flurry of approvals is common at the end of the calendaryear for several reasons, said FDA public affairs spokesmanDon McLearn. Drug companies that have received a so-calledapproval "bull" letter early in the year for some diseaseindications may lobby for more to broaden market share, thensettle for a compromise, perhaps, to gain a decision before theend of the year.
The FDA, he added, has a year-end goal for staff, whose work isaccounted for on a calendar-year basis. He added that newtechnologies, such as Cytogen's MAb-based imaging agent, maytake longer to review because more and more product licenseapplications coming into the FDA have reviewers withbiotechnology expertise stretched thin. However, Congress'recent permission to assess user fees to hire more reviewers,should improve the speed in which applications are processed.
-- Nancy Garcia Associate Editor
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