Pharma Industry News

This information reflects FDA’s current analysis of available data concerning these drugs. ROCKVILLE, Md., Jan. 8, 2009--On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe...
PHILADELPHIA, Jan. 7, 2009 – The combination of estrogen plus progestin, which women stopped taking in droves following the news that it may increase their risk of breast cancer, may decrease their risk of colorectal cancer, according to...
BERKELEY, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Jan 8, 2009 - Plexxikon Inc. and Roche (SWX:ROG), today announced that they have entered into an agreement to develop and commercialize a second novel kinase inhibitor, PLX5568. The main...
WorstPills.org Lists 56 Medications That May Cause Dangerous Interactions or Alter the Effectiveness of Erectile Dysfunction Drugs WASHINGTON, Jan. 6, 2009 – People who take three well-known erectile dysfunction medications should be extremely...
ARLINGTON, Va., January 06, 2009/PRNewswire-USNewswire/ -- HealthCentral (www.HealthCentral.com), the leading collection of online condition-specific consumer health and wellness experiences, today announced that it was identified as one of the top...
USC dentist links Fosomax-type drugs to jaw necrosis LOS ANGELES, Jan 2, 2009-Researchers at the University Of Southern California, School Of Dentistry release results of clinical data that links oral bisphosphonates to increased jaw necrosis. The...
ROCKVILLE, Md., Dec. 31, 2008-Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly...
RARITAN, N.J., December 31, 2008 /PRNewswire/ -- PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., said today that one lot of 50 microgram/hour (mcg/hr) DURAGESIC(R) (fentanyl transdermal system) CII patches sold by PriCara in the...
TORONTO--(BUSINESS WIRE)--Dec 30, 2008 - Biovail Corporation today announced a voluntary recall of certain lots of Ultram® ER (extended-release tramadol hydrochloride) 100mg tablets from pharmacies and wholesalers. Biovail is taking this action...
CHICAGO, Dec. 23, 2008—A survey suggests that nearly half of older adults in the U.S. use prescription and over-the-counter medications together, and that about 4 percent of older adults are potentially at risk of an adverse drug reaction...
    LONDON, December 23, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline (GSK) and Cytokinetics, Incorporated announced today that GSK has informed Cytokinetics that it will not exercise its option to license ispinesib or SB-743921 as...
ROCKVILLE, Md., Dec. 24, 2008--The FDA posted on its web site yesterday a letter it sent to Abbott Laboratories about a review of an American Academy of Dermatology (AAD) Post Meeting News Ad  for Humira. According to the FDA, "This AAD...
Packaged lot #: 90219 Expiration Date: 3/2010 Manufacture Date: 3/6/08 ST. LOUIS, December 23, 2008 /PRNewswire/ -- ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone...
Initiates Nationwide Single Lot Recall of Hydromorphone HCl (2mg) Due to Oversized Tablet ST. LOUIS, December 23, 2008 /PRNewswire-FirstCall/ -- KV Pharmaceutical has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec....
Researchers Use IMS Information to Assess Sales Trends, Healthcare System Opportunities and Risks NORWALK, Conn.--(BUSINESS WIRE)--Dec. 23, 2008--A major reduction in real prescription drug spending growth has created a "turning point" in healthcare...
All Rights Revert to Dynavax BERKELEY, Calif.--(BUSINESS WIRE)--Dec 19, 2008 - Dynavax Technologies Corporation (Nasdaq:DVAX) today announced the termination of a global license and development collaboration agreement with Merck & Co., Inc. for...
ROCKVILLE, Md., Dec. 17, 2008-The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular...
COPENHAGEN, Dec. 17, 2008--H. Lundbeck A/S has initiated a clinical phase III programme with desmoteplase in the treatment of acute ischemic stroke. The programme consists of two phase III clinical placebo-controlled trials, each enrolling...
ROCKVILLE, Md., Dec. 16, 2008-The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of...
ROCKVILLE, Md., Dec. 16, 2008-A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide...
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MedNotes
Latest FDA Drug Alerts
December 31, 2008
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers [UPDATE 12/31/2008] Celgene has issued...
December 24, 2008
Audience: Pharmacists, consumers, primary care healthcare professionals [Posted 12/24/2008] ETHEX and FDA notified heathcare...
December 22, 2008
Audience: Consumers, primary care healthcare professionals [Posted 12/22/2008] FDA alerted consumers nationwide not to purchase...
December 11, 2008
Audience: All healthcare professionals, consumers[Posted 12/11/2008] FDA has become aware of reports of acute phosphate...
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Latest Drug Information Updates

ZolpiMist
Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Epiduo
Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene, and benzoyl peroxide, a well-known antimicrobial.

Nexterone
Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Latisse
Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

BioThrax
BioThrax (Anthrax Vaccine Adsorbed) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age at high risk of exposure.

Mozobil
Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Trilipix
Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

Synthetic Conjugated Estrogens-A (SCE-A) Vaginal Cream
SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

Lusedra
Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Promacta
Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

Banzel
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Apriso
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

LoSeasonique
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Acanya
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

Toviaz
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

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