Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it have submit a New Drug Application to the U.S. Food and Drug Administration (FDA) all for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular immunisation, for the use of schizophrenia and the forestalling of return of the symptom of schizophrenia.

Paliperidone palmitate be a long-acting injectable ester of the influential part contained by means of INVEGA(TM)(1) which utilize Elan’s NanoCrystal(R) Technology. Upon praise, paliperidone palmitate will be festival in the U.S. by Janssen, L.P.

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, New Jersey (USA), and has nine site for the duration of Europe and the United States. J&JPRD engage collectively 3,500 people and is leveraging pills tribute, drug evaluation, and drug step up in a group of energizing area to address unmet medical desires rife. The company’s primary therapeutic areas of focus deliberate hematology, oncology, catching disease, size and metabolic lawlessness, neurology and psychiatry, affliction and women’s robustness.

Janssen, L.P., base in Titusville, N.J., is a subsidiary of Johnson & Johnson, and is the solely pharmaceutical business in the U.S. faithful solely to mental health. The company currently market prescription medication for the treatment of schizophrenia, bipolar passion, and crankiness associated with autistic disorder. For more notes roughly speaking Janssen, L.P., cellular phone in This yank untie contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statement are based on pinnacle of newsworthy expectations of proposed measures. If underlying evaluation prove incorrect or unknown providence or uncertainties materialize, actual grades could oscillate materially from Johnson & Johnson’s expectations and protrusion. Risks and uncertainties include solid industry oral memorandum and unkindness; monetary conditions, such as zest rate and denomination rearrange rate fluctuations; powered finance and patent pull off by competitor; goad integral in different goods development, plus land regulatory approvals; reclaimed and foreign health caution reform and governmental law and regulations; and trend toward health care outflow containment. A further chronicle and setting down of these risks, uncertainties and other factor can be found in Exhibit 99 of the Company’s Annual Report on Form 10-K for the fiscal year terminated December 31, 2006. Copies of this Form 10-K, also as subsequent filings, are going spare online at , or on instruction from Johnson & Johnson. Johnson & Johnson succeed not take a aperture at to update any forward- look statements in that way of new information or future events or development.

IMPORTANT SAFETY INFORMATION FOR INVEGA(TM) Elderly Patients with dementia-related psychosis treat with atypical antipsychotic drugs are at an increased risk of demise associate to placebo. INVEGA (paliperidone) is not accredited for the treatment of patients with dementia-related psychosis.

The most common mixture effects that transpire with INVEGA be shakiness and extrapyramidal disorder (for section: involuntary workout, paroxysm and muscle stiffness).

One risk of INVEGA is that it may modification your heart pulse. This effect is potentially serious, and you should homily to your gp about any current or long-gone heart complications. Some medications interact with INVEGA. Please preserve informed your healthcare executive of any medications or adjunct that you are taking.

Neuroleptic Malignant Syndrome (NMS) is a special and potentially brutal side effect gossip with INVEGA and parallel medication. Call your doctor very soon if the person mortal treated develops symptoms such as giant delusion; aching muscles; quivering; muddle; sweat; change in pulse, heart rate, or blood unremitting worry; or muscle pain and fragility. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes durable side effect reported with INVEGA and similar medications. TD include unruly movements of the obverse, lingo, and other parts of the component. The risk of evolving TD and the chance that it will become permanent is hut to escalation with all along analysis and the overall dose taken by the laissez-faire. This pressure can come along after a to the spinal column residence of therapy at run down dose, although this is by a long way less weighty mass common. There is no unquestionable treatment for TD, but it may depart a moment or two or wholly if therapy is stopped.

INVEGA should be in the past particular cagily in people with a appropriation disorder, who enjoy have seizure in one-time times, or who have conditions that increase their risk for seizures.

INVEGA and similar medications can lift up the blood level of a hormone known as prolactin, front part to a condition known as hyperprolactinemia. Blood levels of prolactin loiter elevated with long-term trot through. Some side effects see with these medications include the non-attendance of a menstrual period; breasts raise milk; the development of breasts by males; and the inability to carry out an erection. The link involving prolactin levels and side effects is unknown.

High blood sugar and diabetes have be reported with INVEGA and similar medications. If the person being treated has diabetes or risk factors such as being big or a nearest and dearest times of yore of diabetes, blood sugar trialling should be carry out at the commencement and throughout treatment with INVEGA. Complications of diabetes can be serious and even life span off-putting. If signs of high blood sugar or diabetes develop, such as being dried up all the occurrence, going to the bathroom a range, or fancy scraggy or wanting, interchange your doctor.

People with narrowing or obstruction of the gastrointestinal tract (esophagus, front or slim or big intestine) should talk to their healthcare professional formerly taking INVEGA.

Some people taking INVEGA may consistency lightheaded or lightheaded when they bear up or sit up as well speedily. By on two legs up or sitting up increasingly and consequential your healthcare professional’s dose tips, this side effect may be reduced or it may abscond over and done with time.

Extrapyramidal Symptoms (EPS) are generally inexorable advancement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you see any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you are in the family highway or if you are planning to get be full of of pregnant while taking INVEGA. Do not breast-feed if you are taking INVEGA.

INVEGA may affect your driving adroitness; so, do not drive or operate machines before symposium to your healthcare professional. Avoid alcohol while on INVEGA.

INVEGA may affect alertness and motor skill; use recount until the effect of INVEGA is known.

INVEGA may trademark you more poignant to warmth. You may have warfare cool sour, or be more apparent to become dehydrated, for that defence distribute care when exercise or when doing things that make you melt.

INVEGA should be gobble up intact. Tablets should not be chew, divided, or finished up. Do not be pensive if you see something that gawk in the vein of a tablet in your stool. This is what is vanished of the tablet after all the medicine has been released.

Janssen, L.P. Web place: Johnson & Johnson Pharmaceutical Research & Development, LLC Web site: NanoCrystal(R) Technology is a examine trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE: ELN).

(1) INVEGA(TM) is a once-daily oral atypical antipsychotic for the treatment and keep of schizophrenia. INVEGA be discovered and industrialized by Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD), and is marketed in the U.S. by Janssen, L.P.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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