Must now have a two -part PI to make it easier to find and review the information. The first part, titled Highlights of the Prescribing Information, usually takes up less than one page, but may be longer, depending on the complexity and extent of the relevant information. This section excludes much of the technical detail, charts/graphs, and less broadly applicable information about the medicine. The second part is the full PI, with specifically labeled and numbered sections.
Although PIs for the older products cover the same types of information as for new products, some of the sections are arranged and labeled a bit differently. For instance, in PIs of older medicines, the topics Medicine Interactions, Use in Special Populations, and Patient Counseling Information. In PIs of newer medicines, each of these three topics is presented as a separate section, and Precautions is part of a combined Warnings and Precautions section, rather than being its own section.
For medicines approved between 2001 and 2006, FDA regulations require the use of the new PI format on a schedule phased in over time. So, not all medicines approved during that time period will be in the new PI format yet, but will be by 2013
Patient age (especially infants or young children, or elderly individuals, for whom the demonstrated effectiveness might be less, or the risk of harmful adverse reactions greater, than for other ages). Patient gender (a risk may be higher, or the effectiveness of the medicine less, for male compared with female individuals). Concomitant therapy (other medicines or treatments already being taken might lead to harmful adverse reactions if this medicine were taken at the same time). Disease state (the risk-benefit relationship might be different for different severities or stages of the disease to be treated). Other condition (a specific coexisting disease or the general condition of a patient might make use of a medicine potentially more hazardous, or less effective against a disease). Patient hypersensitivity to the medicine
Prescribing information & Package insert (Please Comment before download )
Dr Saurav Deka MBBS MD
Medical Advisor INDIA
Zydus International Division
YeAR : 2013
In the U.S., the complete label of a prescription medicine is
made up of several documents that are approved and
required by the Food and Drug Administration (FDA)—some
professionally oriented and some intended for patients and
The first and most comprehensive of these documents is
• Professional Prescribing Information.
Others may include
• Patient Counseling Information
• A patient-oriented Medication Guide..
Prescribing information (PI)
1. Great deal of technical medical detail intended to inform
health care professionals who might prescribe or dispense
2. PI is written for a professional audience.
Package insert or Prescribing information
• Manufacturers typically make the PIs of their medicines
available on the Web, and must include the PI as a printed
―package insert‖ with any medicine that is sold in a box or
other type of package.
• Note that a package insert may also include other
material in addition to the PI
NEWER PRODUCT PI
Must now have a two -part PI to make it easier to find and
review the information.
1. The first part, titled Highlights of the Prescribing
2. The second part is the full PI, with specifically labeled and
OLDER PRODUCT PI
Although PIs for the older products cover the same types of
information as for new products, some of the sections are
arranged and labeled a bit differently.
For instance, in PIs of older medicines has different the
topics under subsections of precautions
• Use in Special Populations,
• Patient Counseling Information.
Three topics is presented as a separate section, Warnings and Precautions section
in newer PI
Indications and usage
The recognized disease or condition for which the
medicine’s use is approved .
I. Treat, prevent, or diagnose or to relieve the
II. Monotherapy or primary therapy or secondary
therapy or combination therapy or adjunctive
III. Approved for certain subgroups of patients
IV. Reserved for certain situations (refractory cases )
Label indication : Approved indication by Regulator
Off label indication : Off-label use is the an unapproved
indication or in an unapproved age group, unapproved
dosage, or unapproved form of administration
The regulator does not have the legal authority to regulate
the practice of the medicine, and the physician may prescribe
a drug off-label.
Off label indication
Drug manufacturer Cannot promote its drug
for an unapproved use, and that any such
promotion is false and misleading simply
because it is not FDA-approved
Many off-label uses are in fact effective and
safe, as is evidenced by subsequent FDA
approval of such uses for numerous drug
However Manufacturers are now able to
provide medical practitioners with
publications on off-label uses of a drug, in
response to an unsolicited request
Medicine should NOT be taken or administered
A contraindication is a judgment by regulators—after
reviewing the available medical evidence—about the
benefit-risk relationship of using that medicine under
The Warnings section of the PI will also include a brief
mention of any contraindications (with cross-references to
Patient hypersensitivity to the medicine.
The defining criterion for inclusion under Warnings is that
a reasonable association must have been established
between the adverse event or risk and the medicine—
although a definitive causal relationship need not be
The Warnings section may also provide information
about nonapproved uses of the medicine.
In the old PI labeling format, actions required to make sure
a medicine is properly and safely used were included
under Precautions if not covered in other sections of the PI
o This term refers to a specially formatted warning that is the
strongest level of safety warning that may be required by
the FDA for an approved medicine.
o Specifically, a boxed warning gives a brief explanation of
any contraindications or serious warnings that may be
associated with death or serious injury, with a crossreference to more detailed information covered in the
Warnings and/or Contraindications sections of the PI.
o If a boxed warning is required, it will be found at the
beginning of the PI, with the text surrounded by a thick
INFORMATION FOR PATIENTS/PATIENT
Patient counseling information
Note that this section may have different titles and locations
within the product label according to when the medicine
and/or its labeling was approved. Whether in the newer or
older format, however, the same types of information are
• Information for Patients is found in PIs for older
medicines.You will find it as a subsection under the
Precautions section near the middle of the PI.
• Patient Counseling Information, on the other hand, is a
separate section at the very end of the PIs for newer
• Is it legal to copy paste innovator PI ?
• Can you use all the indications ?
• How to prepare the Generic drug PI ?
• Do Innovator has patent protection on it’s data ?
Is it legal to copy paste innovator PI ?
If the generic product proves that it is bioequivalent to the
innovator product, the Waxman-Hatch act allows the
generic company to claim the exact labeling content as
the innovator product.
The most recent Reference Listed Drug (RLD) package
insert is available on the FDA web site ―Drugs@FDA‖,
where the most recently approved package insert, the
original package insert and all the subsequent
amendments/changes to the current package insert can
Can you use all the indications ?
The different indications of the RLD may have different
patent expiration dates or exclusivity dates so that some
indications may still be protected under patent or
exclusivity. If this is the case, the generic company can
market the drug only if they ―carve out‖ the
patent/exclusivity protected indication and relevant
information from the RLD labeling.
The generic company must not only carve the patent or
exclusivity protected indication(s) from the
INDICATIONS section of the package insert, they must
carve out all clinical trials data and any other text that
makes any reference to the protected indication.
For example, the RLD product Risperdal® (risperidone)
originally had the indications of
Irritability associated with autistic disorder (paediatric)
Schizophrenia and Bipolar Mania have patent dates and
exclusivity dates that will expire much sooner than that of the
pediatric indication. Thus, in order for a generic company to
submit an ANDA and market the generic risperidone, they
must ―carve out‖ any reference to the pediatric indication.
Which format ?
The proposed package insert document is usually
created in Microsoft Word and submitted as part of the
final labeling folder.
The package insert is also submitted in PDF and SPL
Although prior FDA labeling submission requirements
have been in the MS Word and PDF formats, the FDA
now requires the package insert portion of the labeling
folder to also be submitted in SPL format.
Check list for preparation Generic label
Innovator Package insert with last updated date
Indications ( patent exclusivity check )
Formulation check ( same or not )
Country any deviation (dosage and strength
Resource FOR Generic PI
The DailyMed website has the most updated package
insert in SPL format used by the RLD manufacturer
Regulatory website (eg : US –FDA)
Apply Your Knowledge
True or False
F Enteric-coated tablets can be crushed and
mixed with food. This would allow the drug to be
absorbed sooner than intended.
F All capsules may be opened and mixed with
Some capsules should be swallowed
T Parenteral forms of drugs includes transdermal
Innovator Name in Generic PI
Generic company does not want to
put innovator brand name .
Replace innovator brand name with
• Do not replace with own brand
• Prescribing information is an important
• Prescribing information also a legal document
• Only approve indications should be shared
• Off label indication may lead to legal problems
• It should be update periodically as per latest
update or ruling by regulatory