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Mylan enters settlement agreement with Pfizer for Caduet Tablets litigation

Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. resolving litigation related to Caduet® Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets.

25 Jan 2011

Nordic Naturals launches one-per-day omega-3 fatty acid gels

Nordic Naturals introduces Daily Omega, a line of three products that offers a simple solution for consumers concerned about what type of product to take on a regular basis to address their need for omega-3 essential fatty acids.

25 Jan 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

Kira For Women introduces two new products for menopause, PMS

Natural women's health brand, Kira For Women, is launching two new products - Kira PMS Relief and Kira Menopause Relief.

25 Jan 2011

Sanofi-aventis acquires world-wide license for ADC products

Oxford BioTherapeutics today announces that sanofi-aventis has acquired an exclusive world-wide license to one of OBT's internal preclinical antibody programs.

25 Jan 2011

Strong opposition to 'prescription-only' measures for OTC medicines with pseudoephedrine

More than 300 million Americans get the common cold, and up to 70 million get the flu annually. But for the 60 million people who also have asthma and allergies, a cold or flu can pose even greater risks. Together, these respiratory diseases take a devastating toll on public health, costing billions of dollars in direct medical expenses, reducing quality of life, lowering workplace and school performance, and can even be life-threatening to high-risk populations, such as asthma patients.

25 Jan 2011

ASA concerned over non-availability of sodium thiopental

The American Society of Anesthesiologists (ASA) and its members are extremely troubled to learn that the anesthetic drug, sodium thiopental (Pentothal®), will no longer be available to patients in the U.S. or any other country due to the unfortunate circumstances in Italy that led the sole manufacturer, Hospira, to cease production of the drug.

25 Jan 2011

SNM commends FDA Advisory Committee recommendation for florbetapir approval

The Society of Nuclear Medicine (SNM) commends the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee on its recent recommendation for conditional approval of a new imaging agent, florbetapir.

25 Jan 2011

Researchers find White-Hispanic disparities in receiving immunization against flu, pneumonia

Seniors of Hispanic descent are far less likely to become immunized against the flu or pneumonia compared to similar White seniors, according to a new RAND Corporation study.

25 Jan 2011

FDA approves Matrix's generic Protonix DR Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).

25 Jan 2011

FedEx launches Deep Frozen Shipping Solution for temperature-sensitive healthcare products

FedEx Corp. today announced the launch of FedEx Deep Frozen Shipping Solution, which offers an innovative end-to-end service for the shipping of temperature-sensitive healthcare products around the world.

24 Jan 2011

PediatRx announces first-ever revenues and successful launch of GRANISOL

PediatRx Inc.is pleased to provide an update on activities for the fiscal third quarter. Among its achievements, the hospital specialty pharmaceutical company reported its first-ever revenues and successfully launched GRANISOL™, the company's first commercial entry.

24 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

Spectrum submits Post Approval Supplement for removal of bioscan requirement for Indium-111 ZEVALIN

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement.

24 Jan 2011

BDSI refutes MonoSol's patent infringement claims relating to BEMA Buprenorphine

BioDelivery Sciences International, Inc. today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC. The purpose in responding at this time is for BDSI to strongly refute MonoSol's claims and to assure BDSI stockholders that the Company remains focused on vigorously progressing its pipeline and not allowing this claim to present a distraction.

24 Jan 2011

FDA approves Clinical Data's Viibryd for major depressive disorder

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD).

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

Rotavirus vaccine significantly cuts child hospitalizations, study says

Developing and developed countries that require children to be vaccinated against rotavirus "have significantly reduced the number of children admitted to hospitals with the disease, a report showed on Thursday," Reuters reports (Kelland, 1/20).

24 Jan 2011

Eckert & Ziegler receives European Commission's indefinite approval for YTTRIGA

Eckert & Ziegler Strahlen- und Medizintechnik AG, a firm specializing in radioactive compounds for the treatment of cancer, has renewed the approval of its drug YTTRIGA (Yttrium-90 chloride) by the European Commission. Five years ago the European Medicines Agency EMA approved this drug for the first time and as a result of the current renewal process the drug has now been granted an indefinite approval.

24 Jan 2011

China Shenghuo's Lixuwang product recieves Chinese Well-Known Trademark Honor

China Shenghuo Pharmaceutical Holdings, a China-based pharmaceutical company engaged in the research, development, manufacture, and marketing of Traditional Chinese Medicine, nutritional supplement and cosmetic products, today announced that "Lixuwang", the trademark of its best selling product, Xuesaitong Capsule, was awarded the Chinese Well-Known Trademark Honor by the State Administration for Industry and Commerce of China.

24 Jan 2011