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    Pregnancy Category Jan.14 Ls-1

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    sakti_badala
    The document lists 53 brands and their FDA pregnancy categories. The FDA categories range from A to X, with Category A meaning adequate studies show no risk, and Category X meaning studies show risk that outweighs benefits. Many of the brands listed do not have an official FDA category. The comments provide additional context for several brands, noting some have ingredients found to be safe based on references, while safety data is lacking for others.

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    Pregnancy Category Jan.14 Ls-1

    Uploaded by

    sakti_badala
    179 views15 pages
    The document lists 53 brands and their FDA pregnancy categories. The FDA categories range from A to X, with Category A meaning adequate studies show no risk, and Category X meaning studies show risk that outweighs benefits. Many of the brands listed do not have an official FDA category. The comments provide additional context for several brands, noting some have ingredients found to be safe based on references, while safety data is lacking for others.

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    The document lists 53 brands and their FDA pregnancy categories. The FDA categories range from A to X, with Category A meaning adequate studies show no risk, and Category X meaning studies show risk that outweighs benefits. Many of the brands listed do not have an official FDA category. The comments provide additional context for several brands, noting some have ingredients found to be safe based on references, while safety data is lacking for others.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    179 views15 pages

    Pregnancy Category Jan.14 Ls-1

    Uploaded by

    sakti_badala
    The document lists 53 brands and their FDA pregnancy categories. The FDA categories range from A to X, with Category A meaning adequate studies show no risk, and Category X meaning studies show risk that outweighs benefits. Many of the brands listed do not have an official FDA category. The comments provide additional context for several brands, noting some have ingredients found to be safe based on references, while safety data is lacking for others.

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    SR. NO.

    BRANDS
    ALOGRACE CREAM
    ALOGRACE SYNDET BAR
    1

    ACNESTAR-20

    ARGIPREG SACHET

    ARGIPREG PLUS SACHET

    ASTHAKIND

    ASTHAKIND EXPECTORANT

    ASTHAKIND-DX

    BIOPREG-F
    BIOPREG PLUS
    BONAMOST

    DIZIKIND-MD

    DOLOBAN-AQ

    10

    DROTIKIND-M

    11

    DROTIKIND-80

    12

    DROTIKIND INJ.
    ENERBLESS

    13

    FERIKIND TAB.

    14

    FERIKIND-M SUSP.

    15

    FERIKIND PLUS (RF) INJ.

    16

    FERIKIND SUSP.

    17

    FERIKIND-S 50/100 INJ.

    18

    FLOTRIP FORTE

    19

    FLOTRIP PLUS

    20

    FLUPIDOL

    21

    FOLIMUST-D

    22

    FUL-AID (NF)

    23

    GESTAKIND-10/ SR

    24

    GUDCEF RANGE AND GUDCEF-AZ

    25

    GUDCEF-CV 100

    26

    GUDCEF PLUS

    27

    HERPIKIND TAB.

    28

    HICOPE-25/10

    29

    ILADAY-10

    30

    LEVOSURE-500

    31

    MAXICAL-500

    32

    MATCH-AR

    33

    MATCH INJ.

    34

    MATCH PLUS 4X

    35

    MEFKIND FORTE

    36

    MEFKIND SPAS

    37

    NOBLOK (RF)

    38

    NUCORT-M

    39

    NUCFORCE-CD 3

    40

    NUROSTAR

    41

    NUROSTAR PLUS

    42

    OSKAR-DSR
    ILADAY DSR
    OVABLESS

    43

    ROXIKIND-150
    SCAREND

    44

    TERBINAFORCE

    45

    URIKIND-KM 6
    URIKIND KM SACHET

    46

    VENTIDOX-A

    47

    VENTIDOX-400

    48

    VENTIDOX-DL
    VITAKIND ZIT

    49

    VERMACT-3/6/12

    50

    VERMACT PLUS

    51

    VOMILAST / OD

    52

    ZESTABOLIN-25/50

    53

    HAIRBLESS TAB/LOTION

    The FDA - assigned


    Category A

    Adequate and well-controlled studies have


    evidence of risk in later trimesters).

    Category B
    Animal reproduction studies have failed to
    pregnant women.

    Category C

    Animal reproduction studies have shown an


    humans,but potential benefits may warran

    Category D

    There is positive evidence of human fetal r


    humans,but potential benefits may warran

    Category X

    Studies in animals or humans have demon


    adverse reaction data from investigational
    outweigh potential benefits.

    PREGNANCY CATEGORY
    X
    C
    C
    C
    C
    C
    C
    C
    C
    B

    B
    B
    B
    B
    DATA NOT AVAILABLE
    DATA NOT AVAILABLE
    DATA NOT AVAILABLE
    A
    C
    C
    B
    B
    C
    B
    C
    C
    B

    DATA NOT AVAILABLE

    C
    C
    C
    C
    B
    C
    C
    C
    C
    B

    B
    C
    DATA NOT AVAILABLE
    B
    C
    x
    C
    C
    A
    X
    -

    FDA PREGNANCY CATE


    The FDA - assigned pregnancy categories as used in

    controlled studies have failed to demonstrate a risk to the fe


    ater trimesters).

    n studies have failed to demonstrate a risk to the fetus and t

    n studies have shown an adverse effect on the fetus and the


    al benefits may warrant use of the drug in pregnant women

    idence of human fetal risk based on adverse reaction data fr


    al benefits may warrant use of the drug in pregnant women

    or humans have demonstrated fetal abnormalities and/or the


    ta from investigational or marketing experience, and the ris
    benefits.

    COMMENTS

    L PREPATAION , SO CAN BE GIVEN . It's Ingredients Category is not


    by FDA

    L PREPATAION , SO CAN BE GIVEN . It's Ingredients Category is not


    by FDA

    ne is a nutritional supplement, It's Category is not decided by FDA t


    s safe in Pregnancy. References prove safety and positive outcome

    redients Category is not decided by FDA, But part of B Complex wh


    safe in Pregnancy. References prove safety and positive outcomes

    ngredients Category is not decided by FDA. References prove safety


    positive outcomes
    Shall be taken only on discretion of doctor

    USED AT THE TIME OF DELIVERY FOR CERVICAL DILATION

    ngredients Category is not decided by FDA. References prove safety


    positive outcomes

    NO STUDY SUGGESTS USE IN PREGNANCY


    NO STUDY SUGGESTS USE IN PREGNANCY

    REFERENCES PROVE SAFETY AND POSITIVE OUTCOMES


    CYANOCOBALAMIN IS CATEGORY C DRUG
    REFERENCES PROVE SAFETY AND POSITIVE OUTCOMES

    DATA AVAILABLE REGARDING SAFETY OF ILAPRAZOLE IN PREGNAN

    emisinin derivatives are Category B Drugs, while No data available


    Lumufentrine. Match and Match-AR can be given in Pregnancy

    ONLY IF USED TOPICALLY AS SUPPOSITORIES.

    OT REQUIRED DURING PREGNANCY, SHOULD BE STOPPED WHEN TH


    PREGNANCY IS DETECTED

    ngredients Category is not decided by FDA. References prove safety


    positive outcomes

    BUT CAN BE GIVEN SAFELY

    ngredients Category is not decided by FDA. References prove safety


    positive outcomes

    Should be avoided

    OSITOL IS CATEGORY C DRUG(TABLET) AND MINOXIDIL IS CATEGOR


    DRUG(LOTION)

    Y CATEGORIES

    used in the Drug Formulary are as follows:

    to the fetus in the first trimester of pregnancy (and there is

    tus and there are no adequate and well-controlled studies in

    and there are no adequate and well-controlled studies in


    women despite potential risks.

    n data from investigational or marketing experience or stud


    women despite potential risks.

    nd/or there is positive evidence of human fetal risk based on


    d the risks involved in use of the drug in pregnant women c

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