þÿ
...Deaths attributed to hepatotoxicity have occurred in patients receiving this combination.Patients treated with this combination.....retrospective studies suggest that this infrequent event may be more often associated with.....In 2-year carcinogenicity studies in mice and rats, stavudine was noncarcinogenic at doses..
http://www.fda.gov/medwatch/SAFETY/2002/zerit_label_full.PDF (score=100)

Document
...product contains the following warnings for each ingredient in the combination, listed in.....studies and irritation studies for specific percent as a single active ingredient.....including two clinical studies by Kaplan mineral oil in the first concentration .. the TFM..
http://www.fda.gov/cder/otcmonographs/Skin_Protectant/skin_protectant_FM_20030604.pdf (score=58)

zerit
...In 2-year carcinogenicity studies in mice and rats, HIV disease, a history of neuropathy.....CLUDED DIDANOSINE, WITH OR WITHOUT HY- activity in combination with didanosine and.....Animal reproduction studies are not always pre- greater in patients with impaired renal..
http://www.fda.gov/cder/foi/label/2001/zeritwng.pdf (score=58)

þÿ
...Lifetime carcinogenicity studies were conducted in mice and rats for 22 and 24 months.....When VIDEX is used in combination with other agents with similar toxicities, the incidence.....Because studies have shown VIDEX is in the breast milk of animals receiving the drug, it..
http://www.fda.gov/cder/foi/label/1999/20154LBL.PDF (score=58)

videx
...For information on controlled clinical studies in pediatric patients, see PRECAUTIONS.....FATAL AND NONFATAL PANCREATITIS HAS OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN.....Drug interaction studies have demonstrated that there are no clinically significant..
http://www.fda.gov/cder/foi/label/2001/videxlbl.pdf (score=58)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...In vitro combination activity studies of the antiviral components to rule out antagonistic.....For additional details about food-effect bioavailability studies and fed bioequivalence studies, see the guidance for.....For treatment-experienced patients, the choice of combination regimens is more complex and..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=20)

Guidance for Industry
...based on a collection of well-controlled triple-combination studies that, when evaluated together, 271.....In vitro combination activity studies of the antiviral components to rule out antagonistic.....adequate clinical studies confirming safety and efficacy of the combination have already..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=20)

TO:
...These findings, integrated with the data from the meta-analysis and placebo-controlled.....Acetaminophen in prescription combination medications provides added effectiveness over.....These findings, integrated with the data from the meta-analysis and placebo-controlled..
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882B1_13_McNeil-Acetaminophen.htm (score=19)

intron a pi
...pensated liver disease were used in the clinical studies and should be considered before.....REBETRONTM Combination Therapy containing 1 and 3 by comparison of pretreatment and 6.....Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with INTRON A Interferon alfa..
http://www.fda.gov/medwatch/safety/2002/Intron_A_PI.pdf (score=19)

zyprexa
...However, neither clinical studies nor epidemiologic studies have shown an association.....this drug's efficacy in schizophrenia is mediated through a combination of dopamine and.....phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and..
http://www.fda.gov/medwatch/SAFETY/2004/zyprexa_PI.pdf (score=18)

May 1998 Drug Labeling Changes
...In three studies, 127 women with secondary amenorrhea received estrogen replacement.....These events have been chosen for inclusion due to a combination of their seriousness.....In 18-month studies, in both rats and mice, employing doses up to 150 mg/kg/day there was..
http://www.fda.gov/medwatch/safety/1998/may98.htm (score=18)

ASCO/FDA Lung Cancer Endpoints Workshop: Final Summary
...Pazdur said, including a lack of infrastructure to perform randomized studies and a reluctance to accept foreign studies as relevant.....This study showed and advantage in both response rate and TTP for the combination arm over.....On the other hand, AA has been granted based on tumor response rates from single-arm..
http://www.fda.gov/cder/drug/cancer_endpoints/lungFinalSummary.htm (score=18)

Serzfull0903
...ble-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies.....reuptake, it is recommended that nefazodone not be used in combination with an MAOI, or.....These studies explored SERZONE's use under conditions not evaluat-ed fully at the time..
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_11_Serzone-Label.pdf (score=18)

...When such studies have been conducted, data from the studies must be included in an IND for a botanical drug to assist FDA in its.....Applicability of Combination Drug Regulations Botanical drug products that are derived.....Nonclinical pharmacology and toxicology studies are useful in guiding early clinical studies and in predicting the potential toxicity..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=18)

Food and Drug Administration
...smaller randomized studies was also supportive of the clinical efficacy of anakinra.....USE IN COMBINATION WITH OTHER IMMUNOMODULATORY AGENTS..It is likely that anakinra will.....PEDIATRIC STUDIES..The December 1998 Regulations require studies in pediatric patients if..
http://www.fda.gov/ohrms/dockets/ac/01/questions/3779q1.pdf (score=18)

MONTH YEAR Safety-Related Drug Labeling Changes
...Clinical studies of Levatol did not include sufficient numbers of subjects aged 65 and.....Avandia, like other thiazolidinediones, alone or in combination with other antidiabetic.....Clinical studies of fosinopril sodium/hydrochlorothiazide did not include sufficient..
http://www.fda.gov/medwatch/SAFETY/2001/feb01.htm (score=18)

REGULATORY PROJECT MANAGER
...Studies in "Inpatients"Two studies were conducted to evaluate SERZONE's effectiveness in.....used in combination with an MAOI, or within 14 days of discontinuing treatment..with an.....In animal studies, nefazodone did not act as a reinforcer for intravenous self..
http://www.fda.gov/medwatch/SAFETY/2002/serzone_label.pdf (score=18)

Guidance for Industry Botanical Drug Products
...When such studies have been conducted, data from the studies must be included in an IND for a botanical drug to assist FDA in its.....Consequently, they do not have to meet the requirements for combination drugs, principally.....Nonclinical pharmacology and toxicology studies are useful in guiding early clinical studies and in predicting the potential toxicity..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=18)

REGULATORY PROJECT MANAGER
...Studies in "Inpatients"Two studies were conducted to evaluate SERZONE's effectiveness in.....used in combination with an MAOI, or within 14 days of discontinuing treatment..with an.....In animal studies, nefazodone did not act as a reinforcer for intravenous self..
http://www.fda.gov/medwatch/safety/2002/serzone_label.pdf (score=18)

þÿ
...event profile seen in the Synercid patients in these two studies differed significantly.....In vitro combination testing of Synercid with prototype drugs of the following classes.....Serious adverse reactions in clinical trials, including non-comparative studies..
http://www.fda.gov/cder/foi/label/1999/50748lbl.pdf (score=18)

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