New Drug Approvals in 1992

NDA FDA REVIEW FOREIGN
DRUG COMPANY INDICATION/USE RECEIVED* APPROVED TIME AVAILABILITY
Halfan~ SmithKline Beecham malaria 1/7/92 7/24/92 6.5 months 51 countries
halofantrine (Philadelphia, PA) including:
(P) 1988 France
1991 Germany
1991 Netherlands
DESCRIPTION: For the treatment of multidrug-resistant strains of malaria. (Contact: Sharyn Arnold, 215/751-7074) 1991 UK
HIVID~ Hoffmann-La Roche AIDS 10/31/91 6/19/92 7.6 months USA first
zalcitabine (Nutley, NJ) marketing
(AIDS Drug)
(P)
DESCRIPTION: For treatment, in combination with zidovudine (Retrovir*), of adult patients with advanced HIV-infection
(CD4 cell count S 300 cells/mm3) who have demonstrated significant clinical or immunologic deterioration.
(Contact: Darien E. Wilson, 201/235-4381)
Imitrexmt Glaxo migraine headaches 7/2/90 12/28/92 29.9 months 37 countries
sumatriptan (Research Triangle including:
succinate injection Park, NC) 1991 Nether(P) lands
1991 New
Zealand
1991 Sweden
1991 UK
DESCRIPTION: An injectable for the acute treatment of migraine headaches. Marketed by Cerenex Pharmaceuticals, A Division 1992 Canada
of Glaxo. (Contact: Rick Sluder, 919/248-2839) 1992 Denmark
Lamisil~ Sandoz fungal infections 6/30/91 12/30/92 18.0 months 23 countries
terbinafine HCl Pharmaceuticals including:
cream, 1% (East Hanover, NJ) 1990 UK
(S) 1991 Denmark
1991 Switzerland
1991 Germany
1991 Netherlands
1992 France
DESCRIPTION: For the treatment of athlete's foot, jock itch and ringworm. (Contact. Bill O'Donnell, 201/503-7070)
Manoplax* Boots Pharmaceuticals congestive heart 10/1/90 12/30/92 27.0 months 1992 UK
flosequinan (Lincolnshire, IL) failure
(S)
DESCRIPTION: A once-a-day medication for the management of congestive heart failure in patients not responding adequately
to diuretics (with or without digitalis) who either cannot tolerate an ACE inhibitor or who have not responded
adequately to a regimen including an ACE inhibitor. (Contact: Thomas N. Thurman, 708/405-7434)
Maxaquin~t Searle bacterial infections 7/31/90 2/21/92 18.7 months 14 countries
lomefloxacin HCI (Chicago, IL) including:
(S) 1989 Argentina
DESCRIPTION: A once-a-day, broad-spectrum antibiotic for treatment of acute attacks of chronic bronchitis, complicated 1990 Japan
and uncomplicated urinary tract infections, and prevention of infection in transurethral surgery. (Contact:
Kim Piekos, 708/470-6716)
Mepronm Burroughs Wellcome AIDS-related 4/24/92 11/25/92 7.1 months USA first
atovaquone (Research Triangle pneumonia marketing
(AIDS Drug) Park, NC)
(P)
DESCRIPTION: For the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP), a common opportunistic
infection in people with AIDS, in patients intolerant to trimethoprim/sulfamethoxazole. (Contact: Kathy
Bartlett, 919/248-4302)
Mivacron~ Burroughs Wellcome skeletal muscle 8/30/90 1/22/92 16.8 months USA first
mivacurium (Research Triangle relaxant marketing
chloride Park, NC)
(P)
DESCRIPTION: A short-acting muscle relaxant used in surgery. (Contact: Kathy Bartlett, 919/248-4302)
Mycobutin*t Adria Laboratories mycobacterium avium 1/17/92 12/23/92 11.2 months 1992 Italy
rifabutin (Columbus, OH) complex (MAC)
(AIDS Drug)
(Orphan Drug)
(P)
DESCRIPTION: For the prevention of disseminated Mycobacterium avium complex (MAC), a life-threatening bacterial
opportunistic infection, in patients with advanced HIV infection. (Contact: Bethany Beck, 614/764-8162)