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Internal Medicine News - Risperdal

January 12th, 2009

(risperidone, Janssen)
An atypical antipsychotic for short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, as monotherapy, or in combination with lithium or valproate. Approved in 1994 for schizophrenia.
* Recommended Dosage: Starting at 2-3 mg once daily, reducing or increasing dose by 1 mg/day, no less than 24 hours apart. In short-term trials, from 1- to 6-mg dail…

NJBIZ - J&J Must Supply More Schizophrenia Drug Data to U.S.

January 7th, 2009

NEW BRUNSWICK - Johnson & Johnson must supply more data to United States regulators before they can approve a once-monthly schizophrenia treatment to make up for declining sales of the company’s top -selling drug Risperdal.
The request from the Food and Drug Administration didn’t include a demand for additional studies, New Brunswick-based J&J said in a statement last week. The drug, paliperidone palmitate, is one of two monthly medici…

Chain Drug Review - New uses for Risperdal

January 5th, 2009

WASHINGTON — The Food and Drug Administration has approved Risperdal for two psychiatric conditions in children and adolescents.
Janssen L.P., a unit of Johnson & Johnson, received regulatory clearance for the product to treat schizophrenia (ages 13 to 17) and for the short-term treatment of manic or mixed episodes of bipolar I disorder (ages 10 to 17).

Chain Drug Review - First generic Risperdal

January 3rd, 2009

The Food and Drug Administration has approved the first generic versions of Risperdal (Johnson & Johnson).The agency gave clearance to Teva Pharmaceuticals USA for various product strengths.

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Chain Drug Review - Risperdal request

December 31st, 2008

Janssen Pharmaceutica Products LP has asked the Food and Drug Administration to approve a longer-acting version of Risperdal, its antipsychotic drug. Risperdal would be the first medication of its type available in a formulation suitable for long-term use and administration once every two …

Chain Drug Review - Risperdal dose

December 29th, 2008

The FDA has approved a 12.5-mg dose of Risperdal Consta for schizophrenia treatment. The product, marketed by Janssen LP, is also available in higher doses.

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News: FDA Okays AstraZeneca’s Bipolar Drug and a New Injection …

December 26th, 2008

FDA has given the go-ahead to AstraZenecas bipolar medication Seroquel XR and has sanctioned a new administration option for Janssens Risperdal, indicated for Schizophrenia.
Seroquel XR is the firs…

Business Wire - Janssen’s Risperdal Surpasses Conventional Therapies As No. 1 Prescribed Antipsychotic

December 23rd, 2008

TITUSVILLE, N.J.–(BUSINESS WIRE)–Oct. 1, 1996–Risperdal(R) (risperidone), the drug therapy introduced by Janssen Pharmaceutica in 1994 for the management of psychotic disorders, has become the most often prescribed antipsychotic, capturing 20.7 percent of the market, the company announced today. New prescriptions written for Risperdal surpassed those…

Chemistry and Industry - Risperdal approved for troubled teens

December 21st, 2008

The US Food and Drug Administration (FDA) has approved the use of Risperdal for treatment of two psychiatric disorders in children and adolescents.
Risperdal was approved to treat schizophrenia in 13-17 year olds and bipolar disorder in 10-17 year olds. Approval was granted after two six-eight week trials involving more than 500 children and adole…

News: Alkermes Presents Positive Data on Proprietary Molecules …

December 17th, 2008

Alkermes, Inc. (NASDAQ: ALKS) today announced positive preclinical
results for three proprietary molecules targeting opioid receptors,
including ALKS 33. Data from two preclinical studies demonstrated that
the three molecules showed statistically superior oral efficacy as
well as evidence for improved metabolic and pharmacokinetic profiles
compared to an active control. The data were presented at the 2008
Research Society on Alcoholism/International Soc…