20. November 2009 23:40
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
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Posted in: Child Health News | Pharmaceutical News
Tags: Abilify, Antidepressant, Antipsychotic, Autism, Bipolar Disorder, Blood Pressure, Cardiovascular Disease, Cell, Cerebrovascular Disease, Constipation, Creatinine, Dehydration, Dementia, Depression, Diabetes, Diabetes Mellitus, Dystonia, Exercise, Heart Failure, Hyperglycemia, Hypersensitivity, Insomnia, Leukopenia, Lipids, Nausea, Neutropenia, New Drug Application, Obesity, Pediatrics, Pneumonia, Psychosis, Schizophrenia, Speech, Stroke, Tardive Dyskinesia, Urticaria, Vomiting
20. November 2009 08:11
CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.
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20. November 2009 03:18
Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare.
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20. November 2009 00:52
At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora")., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
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Posted in: Men's Health News | Drug Trial News
Tags: Allergy, Angina, Asthma, Cancer, Cholesterol, Cystitis, Diabetes, Erectile Dysfunction, Incontinence, Interstitial Cystitis, Metabolic Syndrome, New Drug Application, Overactive Bladder, Pediatrics, Premature Ejaculation, Sexual Dysfunction, Stress, Type 2 Diabetes, Urinary Incontinence
19. November 2009 08:36
At the annual meeting of the Sexual Medicine Society of North America, Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company, and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC, today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
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Posted in: Men's Health News | Drug Trial News
Tags: Allergy, Angina, Asthma, Cancer, Cholesterol, Cystitis, Diabetes, Erectile Dysfunction, Incontinence, Interstitial Cystitis, New Drug Application, Overactive Bladder, Pediatrics, Premature Ejaculation, Stress, Type 2 Diabetes
19. November 2009 07:06
Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).
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Posted in: Medical Condition News | Pharmaceutical News
Tags: Calcium, Gabapentin, Immunology, Migraine, Nervous System, Neuroscience, New Drug Application, Oncology, Restless Legs Syndrome, Sleep, Urology
19. November 2009 02:50
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
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18. November 2009 04:01
NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for filing. NicOx submitted the NDA on September 24th, seeking approval for the relief of the signs and symptoms of osteoarthritis.
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18. November 2009 03:55
InterMune, Inc. today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.
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Posted in: Drug Trial News | Pharmaceutical News
Tags: Allopurinol, Biotechnology, Fibrosis, Hepatitis C, Hepatology, Idiopathic Pulmonary Fibrosis, New Drug Application, Peginterferon alfa, Pirfenidone, Ribavirin, Ritonavir, Toxicology, Virus
17. November 2009 03:33
CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).
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17. November 2009 03:13
BioSante Pharmaceuticals, Inc., a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need.
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Posted in: Medical Condition News | Pharmaceutical News
Tags: Brain, Calcium, Cancer, Cell, Contraception, Dopamine, Drug Delivery, Erectile Dysfunction, Estradiol, Estrogen, H1N1, Menopause, New Drug Application, Serotonin, Sexual Dysfunction, Sleep, Swine Flu, Testosterone, Vaccine
17. November 2009 01:29
Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER.
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17. November 2009 01:01
ARCA biopharma, Inc. today announced its planned next steps in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA’s New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. Following receipt of the CRL, the Company and the FDA have held a series of meetings to discuss how best to address the requirements identified in the CRL.
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16. November 2009 10:43
Sciele Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd. and Addrenex Pharmaceuticals, Inc., a privately-held U.S. pharmaceutical company specializing in developing drugs that regulate the adrenergic system, today announced that Sciele has agreed to acquire Addrenex.
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16. November 2009 09:27
Covidien today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.
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