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Investigational drug Debio-025 tested for preventing muscle fiber death in muscular dystrophy

An investigational antiviral drug currently undergoing human trials in Europe for treating Hepatitis C infections may have potential to reduce muscle cell damage in Duchenne and other forms of muscular dystrophy (MD).

17 Mar 2008

FDA steps towards Chinese presence

In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

17 Mar 2008

Watson Pharmaceuticals files application for generic LYBREL

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth.

14 Mar 2008

Oral methadone dosing for chronic pain: practitioner's guide

Methadone, a strong opioid analgesic, is an effective and economical choice for the management of cancer pain and chronic noncancer pain, both as a first line medication and as a replacement opioid.

14 Mar 2008

Aerosol vaccine provides low-cost, needle-free TB treatment

A novel aerosol version of the most common tuberculosis (TB) vaccine, administered directly to the lungs as an oral mist, offers significantly better protection against the disease in experimental animals than a comparable dose of the traditional injected vaccine, researchers report this week in the Proceedings of the National Academy of Sciences.

13 Mar 2008

Barr Pharmaceuticals receives approval for generic Taxol injection

Barr Pharmaceuticals, Inc. announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Bristol-Myers Squibb Company's Taxol (paclitaxel) Injection USP, 6mg/mL, packaged in 100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials.

13 Mar 2008

FDA gives new safety information on proper use of Tussionex as a cough suppressant

The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events - including death - associated with the misuse and inappropriate use of this potent cough medication.

11 Mar 2008

Adapting drug dosing to body size

University of Queensland researchers are leading the charge in adapting drug dosing to a society that is changing shape.

11 Mar 2008

Watson Pharmaceuticals files application for generic SEASONIQUE

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc.

6 Mar 2008

Roche on Tamiflu label revision

Roche has informed healthcare professionals that the prescribing information for Tamiflu (oseltamivir phosphate) has been updated to reflect recommendations made by the FDA Pediatric Advisory Committee at a November 27, 2007 meeting regarding neuropsychiatric events.

6 Mar 2008

New malaria drug also treats toxoplasmosis

A new drug that will soon enter clinical trials for treatment of malaria also appears to be 10 times more effective than the key medicine in the current gold-standard treatment for toxoplasmosis, a disease caused by a related parasite that infects nearly one-third of all humans—more than two billion people worldwide.

6 Mar 2008

Bioniche receives fast track for bladder cancer therapy

Bioniche Life Sciences Inc. has announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its therapy for first-line non-muscle-invasive bladder cancer meets the criteria for Fast Track designation.

6 Mar 2008

Warning of psychiatric side effects with flu drug Tamiflu

Warnings are being issued concerning the drug Tamiflu by both the drug company Roche and the Food and Drug Administration (FDA) in the U.S.

5 Mar 2008

FDA approves Aloxi injection for prevention of postoperative nausea and vomiting

Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

4 Mar 2008

1 in 3 women has pelvic floor disorder

A new study by Kaiser Permanente found that one-third of women suffer from one or more pelvic floor disorders, which include symptoms such as the frequent urge to urinate, dropped pelvic organs, and incontinence.

3 Mar 2008

FDA grants priority review for ACIPHEX (rabeprazole sodium) sNDA for treatment of GERD in adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., has announced that the Food and Drug Administration (FDA) has accepted an ACIPHEX supplemental New Drug Application (sNDA) for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in patients ages 12-16.

3 Mar 2008

FDA approves PRISTIQ for the treatment of adult patients with major depressive disorder

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD).

3 Mar 2008

FzioMed's Oxiplex gel for spine surgery approved in Canada

FzioMed, Inc. (www.fziomed.com) has announced that Health Canada has approved the company's Oxiplex gel for use in lumbar spine surgery.

1 Mar 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

Abilify (aripiprazole) approved for acute treatment of bipolar I disorder in adolescents

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old).

1 Mar 2008