FDA Grants Pediatric Exclusivity For RISPERDAL(R)

The U.S. Food and Drug
Administration (FDA) has granted pediatric exclusivity for RISPERDAL(R)
(risperidone), based on studies conducted in bipolar 1 disorder and
schizophrenia. The patent is set to expire in December 2007, however, this
grant will extend the period of exclusivity on risperidone through June
2008.


RISPERDAL is approved in the U.S. to treat acute manic or mixed
episodes of Bipolar I Disorder and for the treatment of schizophrenia in
adults. It is marketed by Janssen, L.P.


In October 2006, RISPERDAL(R) was also approved in the U.S. for the
treatment of irritability associated with autistic disorder, including
symptoms of aggression towards others, deliberate self-injuriousness,
temper tantrums, and quickly changing moods, in children and adolescents
ages 5 to 16 years. That indication was the first time the FDA approved any
medication for use in children and adolescents with autism.


This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Johnson & Johnson's expectations and
projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of Johnson & Johnson's
Company's Annual Report on Form 10-K for the fiscal year ended December 31,
2006. Copies of this Form 10-K, as well as subsequent filings, are
available online at sec or on request from Johnson & Johnson.
Johnson & Johnson does not undertake to update any forward-looking
statements as a result of new information or future events or developments.


IMPORTANT SAFETY INFORMATION


Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
RISPERDAL (risperidone) is not approved for the treatment of patients with
Dementia-Related Psychosis.



The most common side effects are sleepiness, increased appetite,
fatigue, upper respiratory tract infection, increased saliva, constipation,
dry mouth, tremor, muscle stiffness, dizziness, repetitive behavior,
involuntary movement, rapid heartbeat, confusion and weight increase.















Studies suggest an increased risk of elevated blood sugar-related side
effects, and sometimes potentially fatal, in patients treated with this
class of medications, including RISPERDAL. Some people may need regular
blood sugar testing.


You may have heard the term "tardive dyskinesia." These are usually
persistent, uncontrollable, slow or jerky facial or body movements that can
be caused by all medications of this type. If you or your child observe
these symptoms, talk to your healthcare professional.



A rare but serious side effect that has been reported with this kind of
medicine, including RISPERDAL, is known as neuroleptic malignant syndrome
(NMS). NMS is characterized by muscle rigidity, fever and can be serious.



Some people taking RISPERDAL may feel faint or lightheaded when they
stand up or sit up too quickly.



You may have heard the term "extrapyramidal symptoms" (EPS). These are
usually persistent movement disorders or muscle disturbances, such as
restlessness, tremors, and muscle stiffness. If you or your child observe
these symptoms, talk to your healthcare professional.



Some medications interact with RISPERDAL. Please inform your healthcare
professional of any medications or supplements that you are taking. Avoid
alcohol containing products while on RISPERDAL.



Inform your healthcare professional if you are already pregnant or if
you are planning to get pregnant while taking RISPERDAL. Do not breast-feed
if you are taking RISPERDAL.



RISPERDAL may affect alertness and motor skills; use caution until the
effect of RISPERDAL is known.



Keep out of reach of children.



Approved for marketing in more than 100 countries, RISPERDAL(R) is the
most widely prescribed atypical antipsychotic in the world. Janssen, L.P.
has marketed RISPERDAL(R) in the United States since 1994. It is given as
an oral tablet, a quick-dissolve tablet or an oral solution. For more
information, visit risperdal.



Based in Titusville, N.J., Janssen, L.P. currently markets prescription
medications for the treatment of schizophrenia, bipolar disorder and for
the treatment of irritability associated with autistic disorder. For more
information, visit janssen.


Janssen, L.P.

janssen



View drug information on Risperdal Oral Formulation.