Focalin: profile and news






Shire calls for ADHD drug studies after US moves to strengthen ...  Feb 10, 2006
Other drugs in the stimulant class examined by the Food and Drug Administration include Novartis AG's Ritalin and Focalin and Johnson & Johnson's Concerta. ... - Forbes

Warning labels recommended for ADHD drugs  Feb 10, 2006
...and 1 million adults are currently on ADHD drugs, which include amphetamines, such as Adderall, and methylphenidates, such as Ritalin, Focalin and Metadate. ... - Contra Costa Times,

Attention-Deficit Drugs Need Added Warnings, US Advisers Say  Feb 9, 2006
...versions. Other drugs of the types under review include Johnson & Johnson's Concerta, Novartis's Focalin, and Mallinckrodt Inc. ... - Bloomberg

Attention Drugs Need Strictest Warning, Panel Says (Update2)  Feb 9, 2006
Other stimulants include Johnson & Johnson's Concerta, Novartis's Focalin, and Tyco International Ltd. and Alliant Pharmaceuticals Inc.'s Methylin. ... - Bloomberg

Attention-Deficit Drugs Need Watching, US FDA Says (Update1)  Feb 8, 2006
Other drugs included in the types the panel will review are Eli Lilly & Co.'s Strattera and Novartis's Focalin. The FDA said that as of Dec. ... - Bloomberg

ADHD Drugs May Get Black Box  Feb 9, 2006
Other prominent brand names include Concerta from Johnson & Johnson (JNJ:NYSE - commentary - research - Cramer's Take) and Focalin from Novartis. ... - TheStreet.com

Advisers urge heart risk warning on ADHD drugs  Feb 9, 2006
...said. Concerta is part of a family of treatments known as methylphenidates that includes Ritalin and another Novartis drug, Focalin. ... - Reuters.uk,

ADHD Individual Drug Risk Studies To Be Considered By Drug Safety ...  Feb 8, 2006
...s Methylin and Methylin ER; UCB/Celltech’s Metadate ER and Metadate CD), methamphetamine (Ovation’s Desoxyn) and dexmethylphenidate (Novartis’ Focalin). ... - FDA Advisory Committee

Analysis: ADHD drug risks won't hurt sales  Feb 9, 2006
The FDA report noted that conclusions about the safety of Ovation's Desoxyn and Novartis' Focalin could not be reached due to the relatively low use of these ... - United Press International

Warnings Advised on ADHD Drugs  Feb 10, 2006
...asked the committee to consider what types of studies could be used to look at whether the drugs, which include Ritalin, Adderall, Focalin, Methylin, Metadate ... - Sci-Tech Today

Re-examining ADHD drugs  Feb 17, 2006
...educators.". New drugs like Stratera and Focalin are coming out, too, that treat the disorder without stimulants, according to Meyers. ... - myDNA.com,

ADHD Individual Drug Risk Studies To Be Considered By Drug Safety ...  Feb 8, 2006
...s Methylin and Methylin ER; UCB/Celltech’s Metadate ER and Metadate CD), methamphetamine (Ovation’s Desoxyn) and dexmethylphenidate (Novartis’ Focalin). ... - FDA Advisory Committee

Celgene Corporation Reports Record Operating Performance for 2005  Jan 26, 2006
The FDA granted approval for FOCALIN XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention- Deficit/Hyperactivity Disorder ... - PR Newswire (press release),

Revenue Rises at Celgene  Jan 26, 2006
Food and Drug Administration approval to market Revlimid for myelodysplastic syndromes and clearance for its extended-release version of Focalin for attention ... - TheStreet.com

Celgene Corporation Reviews Recent Highlights and Outlines 2006 ...  Jan 9, 2006
...was attributed to growing product revenue and profits supported by multiple product revenue streams including, THALOMID(R), ALKERAN(R), FOCALIN XR(TM) and the ... - MSN Money

Bellaire man faces charges in heist  Jan 11, 2006
...well as a PlayStation 2, 10 games, a black purse containing birth certificates, Social Security cards, shot records, and two prescriptions for Zanax and Focalin ... - Martins Ferry Times Leader,

Novartis' sales climb 14% in fourth quarter  Jan 19, 2006
Focalin (dexmethylphenidate) for attention deficit hyperactivity disorder has started well with $46 million in sales in its first six months on the US market ... - Pharma Times (subscription),

Celgene Corporation Reviews Recent Highlights and Outlines 2006 ...  Jan 9, 2006
...performance was attributed to growing product revenue and profits supported by multiple product revenue streams including, THALOMID®, ALKERAN®, FOCALIN XR(TM ... - Yahoo! News (press release)

Treatment For Adult ADHD Is On The Rise:  Dec 9, 2005
After being diagnosed with ADHD, Tim began treatment with Focalin XR(tm) (dexmethylphenidate HCl) extended-release capsules, a new, once-daily medication ... - Devine Media,

On call: Pay attention to ADHD disorder, part II  Nov 26, 2005
Products approved for ADHD treatment in children have the brand names of Ritalin, Concerta, Dexedrine, Adderall, Focalin, Metadate and others. ... - Waldo Village Soup,

Celgene halted for FDA vote  Sep 14, 2005
...cancer multiple myeloma. Celgene also receives royalties on the attention-deficit drugs Ritalin and Focalin, marketed by Novartis. - MarketWatch

FDA panel backs Celgene's cancer drug  Sep 14, 2005
...myeloma. Celgene also receives royalties on the attention-deficit disorder drugs Ritalin and Focalin, marketed by Novartis (NVS). - Investor's Business Daily (subscription)

Are ADHD drugs safe? Report finds little proof  Sep 13, 2005
The 27 drugs studied included Adderall, Concerta, Strattera, Ritalin, Focalin, Cylert, Provigil, and others that, in some households, are well-known for their ... - TheNewsTribune.com (subscription),

Celgene Corporation Reports Record Operating Performance and Key ...  Jul 28, 2005
Total revenue for the second quarter, including a $20 million milestone payment for the NDA approval of FOCALIN XR(TM), increased 66.0% to $145.7 million from ... - Yahoo News (press release)

UPDATE 1-Celgene quarterly profit rises on Thalomid sales  Jul 28, 2005
Total revenue rose 66 percent to $145.7 million, helped by a $20 million milestone payment for regulatory approval of Focalin XR, a treatment for attention ... - Reuters

Celgene: A Biotech With Profits And A Pipeline  Jul 6, 2005
...allowed it to partner with Novartis (nyse: NVS - news - people ), and the two of them recently received approval from the FDA to sell once-a-day Focalin XR for ... - Forbes

Why is my child like that?  Jul 16, 2005
Now, the pharmaceutical market is saturated with options: Adderall, Concerta, Focalin, Ritalin, Wellbutrin, Desipramine and Imipramine are among them. ... - Edmond Sun <**results**>

Focalin XR(TM) Approved for Treatment of ADHD in Adults ...  Jun 12, 2005
The FDA has just approved focalin XR(TM), a new long-acting medication for adults, adolescents and children who struggle with attention- deficit/hyperactivity ... - Medical News Today

Garden State Business Briefs  Jun 27, 2005
Their primary products are Thalomid and Alkeran, and the company receives royalties for sales of Focalin and the Ritalin family of drugs. ... - Newark Star Ledger

Celgene: A Biotech With Profits And A Pipeline  Jul 6, 2005
...allowed it to partner with Novartis (nyse: NVS - news - people ), and the two of them recently received approval from the FDA to sell once-a-day Focalin XR for ... - Forbes

Teacher quits amid probe of med thefts  Jun 17, 2005
...the nurse’s office at Northwood, 1201 E. Washington Center Road, after repeated thefts of medications including Ritalin, Concerta, Focalin and Citelopram. ... - Fort Wayne Journal Gazette,

Focalin XR(TM) Approved for Treatment of ADHD in Adults ...  Jun 12, 2005
The FDA has just approved focalin XR(TM), a new long-acting medication for adults, adolescents and children who struggle with attention- deficit/hyperactivity ... - Medical News Today,

FDA Grants Approval to Market Focalin XR(TM) for the Treatment of ...  May 27, 2005
NJ, May 27 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that the US Food and Drug Administration (FDA) has approved Focalin XR(TM ... - PR Newswire (press release)

FDA Grants Approval to Market FOCALIN XR(TM) for the Treatment of ...  May 27, 2005
FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that Novartis Pharma AG, its partner in the development and commercialization of FOCALIN XR, was ... - PR Newswire (press release)

FDA Grants Approval to Market FOCALIN XR(TM) for the Treatment of ...  May 27, 2005
May 27 /PRNewswire-FirstCall/ -- Celgene Corporation announced that Novartis Pharma AG, its partner in the development and commercialization of FOCALIN XR, was ... - mysan.de (Pressemitteilung),

FDA Grants Approval to Market Focalin XR for the Treatment of ADHD ...  May 27, 2005
NJ, May 27, 2005 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that the US Food and Drug Administration (FDA) has approved Focalin XR(TM ... - PharmaLive.com (press release),

FOCALIN XR (TM) Approved for Treatment of ADHD in Adults ...  May 27, 2005
The FDA has just approved FOCALIN XR(TM) for the treatment of Attention- Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children. ... - Yahoo News (press release)

FDA Approvals: Focalin XR, Merrem IV, Tramadol ODT  Jun 2, 2005
On May 26, the FDA approved an extended-release formulation of dexmethylphenidate HCl (Focalin XR capsules, made by Novartis Pharma AG under license from ... - Medscape (subscription)

Focalin XR(TM) Approved for Treatment of ADHD in Adults ...  Jun 10, 2005
THE FDA HAS JUST APPROVED FOCALIN XR(TM), A NEW LONG-ACTING MEDICATION FOR ADULTS, ADOLESCENTS AND CHILDREN WHO STRUGGLE WITH ATTENTION- DEFICIT/HYPERACTIVITY ... - RedNova.com,

FOCALIN XR (TM) Approved for Treatment of ADHD in Adults ...  May 27, 2005
NEW YORK, May 27 /PRNewswire/ -- NEWS: FDA approves FOCALIN XR(TM), a long-acting medication that helps control the symptoms of Attention-Deficit/Hyperactivity ... - PR Newswire (press release)

FDA Approves Dexmethylphenidate ER Capsules for the Treatment of ...  May 27, 2005
By Novartis Pharmaceuticals , Novartis Pharmaceuticals Corporation today announced that the US Food and Drug Administration (FDA) has approved Focalin XR(TM ... - RxPG NEWS,

Thalidomide's successor propels Celgene to No. 9 slot in biotech  May 29, 2005
...the pipeline. Celgene is awaiting a decision on Focalin XR, an extended-release drug for ADHD, a $3 billion-a-year market. The long ... - San Mateo County Times,

Now No. 9 in Biotech Celgene Corp's Climb to the Top Began With ...  May 30, 2005
...$40.90. Those numbers could improve still. Celgene is awaiting an FDA decision on Focalin XR, an extended-release drug for ADHD. The ... - RedNova.com,

Novartis gets FDA approval for ADHD drug  May 27, 2005
The agency approved Focalin XR for the treatment of ADHD in adults, adolescents and children, based on clinical trial results that showed adults responded well ... - BusinessWeek

Business news in brief from around New Jersey  May 27, 2005
EAST HANOVER, NJ -- Federal regulators have approved Novartis Pharmaceuticals Corp.'s Focalin XR, the company said Friday. The drug ... - Newsday,

ISEQ gains on AIBIM sale rumours  May 30, 2005
Elsewhere, troubled Irish drugs firm, Elan, managed a gain of 15c to 635 after Novartis announced that the US FDA had approved Focalin XR, an extended-release ... - Business World,

Drug shown effective for treating 'chemobrain'  Jun 4, 2005
...with chemotherapy-related fatigue and cognitive impairment were treated with the central nervous system stimulant dexmethylphenidate (Focalin®) or an inactive ... - Cancerfacts.com

Teacher quits amid probe of med thefts  Jun 17, 2005
...the nurse’s office at Northwood, 1201 E. Washington Center Road, after repeated thefts of medications including Ritalin, Concerta, Focalin and Citelopram. ... - Fort Wayne Journal Gazette,

S&P Keeps Hold on Computer Associates  May 27, 2005
...estimate. Novartis gets the FDA okay for Focalin XR to treat attention deficit hyperactivity disorder. Celgene is entitled to royalties. ... - BusinessWeek

TiVo Narrows Loss  May 27, 2005
51Job Inc. (JOBS ) sets a $25 million share (ADS) buyback. Celgene Corp. (CELG ) says the FDA approved Focalin XR extended-release capsules for the treatment ... - BusinessWeek


Other information


Indication
Children with attention deficit disorders

Pharmacology
Methylphenidate, a central nervous system stimulant chemically similar to the amphetamines, is used to treat narcolepsy, attention-deficit hyperactivity disorder (ADHD) in children, post-stroke depression or other depressive disorders.

Mechanism Of Action
Methylphenidate blocks dopamine uptake in central adrenergic neurons by blocking dopamine transport or carrier proteins. Methylphenidate acts at the brain stem arousal system and the cerebral cortex and causes increased sympathomimetic activity in the central nervous system. Alteration of serotonergic pathways via changes in dopamine transport may result.

Drug Category
Adrenergic Agents; Dopamine Agents; Central Nervous System Agents; Anorexigenic Agents; Stimulants; ATC:N06BA04

Brand Names/Synonyms
4311/B Ciba; C 4311; CHEMBANK1663; Calocain; Centedein; Centedrin; Centedrine; Centredin; Concerta; Dea No. 1724; Focalin; Focalin Xr; HSDB 3126; METHYLPHEN; Meridil; Metadate; Metadate Cd; Metadate Er; Methyl Phenidyl Acetate; Methylin; Methylin Er; Methylofenidan; Methylphenidan; Methylphenidate; Methylphenidate Hcl; Methylphenidate Hydrochloride; Methylphenidatum [Inn-Latin]; Methylphenidylacetate Hydrochloride; Methypatch; Metilfenidat Hydrochloride; Metilfenidato [Inn-Spanish]; Metilfenidato [Italian]; Phenidylate; Plimasine; Pms-Methylphenidate; Riphenidate; Ritalin; Ritalin Hydrochloride; Ritalin La; Ritalin Sr; Ritalin-Sr; Ritaline; Ritcher Works

Dosage Forms
Tablets, SR tablets

Absorption
readily absorbed in a biphasic manner. It reaches peak absorption at approximately two hours for the first phase and five hours for the second phase. bioavailability is low (approx. 30%)

Interactions
-->Interactions for Methylphenidate:

Ritalin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that Ritalin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Ritalin.

Serious adverse events have been reported in concomitant use with clonidine, although no causality for the combination has been established. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systemically evaluated.

 


Chemical IUPAC Name
methyl2-phenyl-2-(2-piperidyl)ethanoate

Chemical Formula
C14H19NO2

Half Life
2.4 hours in children and 2.1 hours in adults

Drug Type
Approved Drug

# Accession No
APRD00657

CAS Registry Number
113-45-1


Home | About | Cancers | Treatment | Medications
Copyright onconews.org 2005.
All Rights Reserved.
Google
 
Web onconews.org