Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome
PALO ALTO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK ) today announced that the positive results from a Phase 1 multicenter, dose escalation study of ezatiostat hydrochloride (TELINTRA, TLK199)
tablets in patients with Myelodysplastic Syndrome (MDS) have been p...
Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
Data Findings Published in June Issue of Circulation
SILVER SPRING, Md. and INDIANAPOLIS, June 9 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) and Eli Lilly and Company (NYSE: LLY ) today announced the results of a pivotal 16-week study showing that a once-dail...
New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
Data Confirm Tapentadol Efficacy and Tolerability for Acute Pain Patients
RARITAN, N.J., May 26 /PRNewswire-USNewswire/ -- It is estimated that up to 30 percent of all people who have surgery experience gastrointestinal side effects, such as nausea and vomiting. The use of opioid pain medicin...
FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
Conference Call to be Held at 9:00 a.m. Eastern Time Today, May 26, 2009
SILVER SPRING, Md., May 26 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) announced today that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablet...
Three Clinical Presentations on Tapentadol Extended Release Tablets for Chronic Pain Featured at 2009 American Pain Society Annual Meeting
Safety and Efficacy Data from Phase 3 Study will be Highlighted
SAN DIEGO, May 7 /PRNewswire-USNewswire/ -- Chronic pain is a significant medical challenge in the United States, and chronic low back pain is the most common cause of disability in developed countries. An estimated 100 million A...
Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis
- Primary Endpoint met With a Significant Reduction in Relapse Rate
- Secondary Endpoints met Including MRI Measures, Proportion of Patients Relapse-Free and Disability Progression
- Submission for Registration of Cladribine
Tablets Planned for mid-2009
SEATTLE and GENEVA, April 30 ...
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
RARITAN, N.J., Nov. 21 /PRNewswire/ -- Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Dru...
Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease
-- Exploratory study shows clinical improvement in patients with pulmonary arterial hypertension (PAH)
-- Current treatment options have limited benefit for this debilitating, rapidly progressive and incurable blood vessel disease
-- Imatinib mesylate, available as Gleevec(R)...
Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis
- ORACLE MS Phase III Trial Will Assess Effectiveness of Cladribine Tablets
in Preventing Conversion to Definite Multiple Sclerosis in Addition to the Fully Enrolled Phase III Pivotal Trial - - the CLARITY Study - - for Treatment of Relapsing Forms of...
Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder
Ambien CR(R) 12.5 mg significantly improved sleep onset, sleep maintenance and total sleep time compared to placebo
BRIDGEWATER, N.J., June 10 /PRNewswire-FirstCall/ -- Sanofi-aventis
announced today results from a new study that showed Ambien CR(R) (zolpidem
tartrate extended-re...
Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Clinical studies show Treximet provided significantly more patients migraine pain relief compared to sumatriptan 85 mg
LONDON, April 15 /PRNewswire-FirstCall/ -- GlaxoSmithKline (LSE: GSK)
(NYSE: GSK ) and POZEN Inc. (Nasdaq: POZN ) announced today that the FDA has
approved Trexi...
Keppra XR(TM) Extended-Release Tablets Filed with the FDA
U.S. Food and Drug Administration (FDA) has accepted for filing the New
Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) in the
adjunctive treatment of partial onset seizures in adults with epilepsy
ATLANTA, Jan. 16 /PRNewswire/ -- UCB announced today that the New Drug
A...
A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
REHOVOT, Israel, Nov. 6 /PRNewswire/ -- Meditor Pharmaceuticals Ltd.
announced today that the primary end point and safety evaluation in the
Phase II, Randomized Double Blind, Placebo-Controlled Dose-Escalating Study
in Migraine patients was successfully completed. This event marks a major
mil...
New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV
Study Confirms Role of AMBIEN CR in Effectively Managing Insomnia to Improve Quantity and Quality of Work Performance
BRIDGEWATER, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Sanofi-aventis
today announced results from a new study that showed patients with chronic
insomnia who were tr...
Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
PRINCETON, N.J., Aug. 20 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc.
(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),
announced today that RLL has received approval from the U.S. Food and Drug
Administration to manufacture and market Hydrocodone Bitartrate and
Acetamino...
Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets
CINCINNATI, July 7 /PRNewswire/ -- Procter & Gamble Pharmaceuticals (P&GP) announced today the availability of Asacol HD (mesalamine) delayed-release tablets, which are indicated for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involv...
TriMix Gel Achieves Success Among Men Who Have Failed to Achieve Erections With Viagra, Levitra and Cialis Type Tablets
ORLANDO, Fla., June 5 /PRNewswire/ -- New research presented at the
recent American Urological Association Conference by Urologist Joel L.
Marmar, M.D., showed that among men who previously failed to achieve
erections on Viagra, Levitra and Cialis type tablets, 40% achieved an
erection suffici...
Lotus Pharmaceuticals, Inc. Achieves Significant Milestones in the Development of Isosorbide Mononitrate Sustained Release Tablets
BEIJING, Feb. 6 /Xinhua-PRNewswire-FirstCall/ -- Lotus Pharmaceuticals,
Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a
pharmaceutical company in the People's Republic of China ("PRC"), today
announced that it has achieved significant milestones in the development of
isosorbide m...
UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets
Keppra XR(TM) significantly reduced partial onset seizure frequency when
administered as adjunctive therapy for adults with refractory epilepsy.
ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced results of a Phase
III trial demonstrating that its antiepileptic drug (AED) in development
Kep...
Blood Levels of Paliperidone Extended-Release Tablets are Not
Increased by Common Antidepressant
Study shows paroxetine produced no significant drug interaction
with paliperidone ER
SAN DIEGO, May 22, 2007 /PRNewswire/ -- After administration of
paliperidone extended-release (ER) tablets, blood levels of the
drug were not affected when given with a common antidepressant,
according to new data...
July Issue of Journal of Antimicrobial Chemotherapy Highlights
Study of Factive Tablets for Five-Day Treatment of
Community-Acquired Pneumonia
WALTHAM, Mass.--(BUSINESS WIRE)--Jun 12, 2007 - Results from the
successful clinical trial of Oscient Pharmaceuticals' (Nasdaq:
OSCI) FACTIVE(R) (gemifloxacin mesylate)
tablets for the five-day
treatment of community-acquired pneumonia of mild to moderate
severity (CAP) have been published in the J...
Critical Therapeutics Announces the Publication of Data for ZyfloCR
(Zileuton) Extended-Release Tablets in the Journal of Asthma
LEXINGTON, Mass.--(BUSINESS WIRE)--Jun 12, 2007 - Critical
Therapeutics, Inc. (Nasdaq: CRTX) today announced the publication
of data from a pivotal Phase III clinical trial of ZYFLO CR(TM)
(zileuton) extended-release
tablets in the June 2007 issue of the
Journal of Asthma. ZYFLO CR was approved by ...
Salix Pharmaceuticals Announces Positive Top Line Results of
Balsalazide Tablets Registration Study
RALEIGH, N.C.--(BUSINESS WIRE)--Jun 18, 2007 - Salix
Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful
completion and outcome of its Phase III registration trial to
evaluate the safety and efficacy of a new 1100 mg tablet
formulation of balsalazide disodium (balsalazide tablets).
B...
New Data Presented on Micardis (Telmisartan) Tablets in
Hypertensive Patients With Type 2 Diabetes
RIDGEFIELD, Conn., June 18, 2007 /PRNewswire/ -- Today, results
from AMADEO*, one of a series of studies comparing two angiotensin
receptor blockers (ARBs) in hypertensive patients with diabetic
nephropathy, were presented at the 17th annual European Meeting on
Hypertension in Milan, Italy.
The ...
NovaDel Announces Positive Data from Two Studies Comparing Zolpidem
Oral Spray to Ambien Tablets
FLEMINGTON, N.J.--(BUSINESS WIRE)--Jun 5, 2007 - NovaDel Pharma
Inc. (AMEX: NVD), a specialty pharmaceutical company developing
oral spray formulations for a broad range of marketed treatments,
today announced that its two clinical studies comparing zolpidem
oral spray with zolpidem
tablets have me...
FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
...e U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual
tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute tre...
FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
...turna HCT((R)) (aliskiren and hydrochlorothiazide)
tablets as initial therapy for patients who are likely to ...
Tekturna HCT is available in four strengths as
tablets containing aliskiren and hydrochlorothiazide: 150 ...5 mg tablets, 150 mg/25 mg tablets, 300 mg/12.5 mg
tablets and 300 mg/25 mg tablets.
Study details ...
Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)
...ostherpetic neuralgia; PERCOCET(R) and PERCODAN(R)
tablets for the relief of moderate-to-moderately severe pain; FROVA(R)
tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R)
tablets for the relief of moderate-to-severe acute pain wh...
Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)
...A) for Acurox (oxycodone HC1, USP and niacin, USP)
tablets CII, an immediate release product intended for the...submission of their response.
About Acurox
tablets
Acurox is a patented, orally administered, imme...ies of tablets, intravenous injection of dissolved
tablets and nasal snorting of crushed tablets. The Acurox...
Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Patient Value
...e to patients with Alzheimer's disease. As progress in those programs has been made, Eisai announces the status as follows:
1. Sustained Release
tablets
Eisai has completed a Phase III study of Aricept 23 mg sustained release (SR) in patients with moderate to severe Alzheimer's disease. Aricept 23...
Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
...d Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil)
tablets [C-IV] for the indication of improved wakefulness in patients with excessiv...) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil)
tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The comp...
King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use
...s follows:
ACUROX(R) (oxycodone HCl/niacin)
tablets for the Treatment of Acute, Moderate to Severe Pai...ionectomy Surgery in Adult Patients
ACUROX(R)
tablets are a unique composition of short-acting oxycodone...The 405 participants received either two ACUROX(R)
tablets 7.5/30 mg, two ACUROX(R) ...
Cephalon Provides Clinical Update on Lestaurtinib in Relapsed Acute Myelogenous Leukemia
...proprietary products in the United States include: NUVIGIL(R) (armodafinil)
tablets [C-IV], TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release c...], TRISENOX, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil)
tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The compan...
Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial
...ients with the most common type of non-Hodgkin's lymphoma
EAST HANOVER, N.J., June 8 /PRNewswire/ -- New data show that Afinitor(R) (everolimus)
tablets significantly shrunk tumors in 33% of patients with relapsed non-Hodgkin's lymphoma (NHL) and Hodgkin's disease(1). Based on results from this study a...
IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant
...be as high as 90%.
About Valcyte
Valcyte
tablets are indicated for the treatment of CMV retinitis i...ogenic, and caused aspermatogenesis.
Valcyte
tablets should not be administered if the absolute neutrop...ave been observed in patients treated with Valcyte
tablets (and ganciclovir). Other adverse events reported w...
Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
...nd efficacy of the 5-ASA products and no such conclusions can be drawn from its results.
About LIALDA
Important Safety Information
Lialda
tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda beyond 8...
Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
...ived daily treatment with Afinitor(R) (everolimus)
tablets had tumors that stabilized or reduced in size(3). ...dvised to not become pregnant while taking Gleevec
tablets and to avoid breast-feeding while taking Gleevec
tablets because of the potential for serious adverse react...
Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults
... increased to a daily dose of 200 to 400 mg per day (recommended therapeutic dosing) administered in two divided doses. Vimpat(R) is available as oral
tablets and as an intravenous (IV) infusion to allow for consistent treatment in an emergency room or hospital setting. These formulations are bioequivalent, ...
Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples
...avoid long-term injury.
In rare instances, men taking prescription ED
tablets (including Cialis) reported a sudden decrease or loss of vision, or a sudde...'s not possible to determine if these events are related directly to the ED
tablets or to other factors. If a man has a sudden decrease or loss of vision or he...
New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
...gating the efficacy, safety and tolerability of pramipexole dihydrochloride
tablets in an extended release, once-daily formulation, for the treatment of Parkin...
A once-daily, extended release formulation of pramipexole dihydrochloride
tablets is currently under review by the U.S. Food and Drug Administration for the ...