KING OF PRUSSIA, Pa.
,
Jan. 5
/PRNewswire/ -- Prism Pharmaceuticals
announced today that the U.S. Food & Drug Administration (FDA) has approved
the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a
novel, patent-protected, cosolvent free formulation of the antiarrhythmic
agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R)
Intravenous. NEXTERONE is indicated for the treatment and prophylaxis Read the rest of this entry »

Dec 23, 2008 (Datamonitor via COMTEX) --
-- Novartis has announced that its Gleevec tablets have received approval from the FDA for the post-surgery treatment of adult patients following complete surgical removal of Kit-positive gastrointestinal stromal tumors.
According to the company, Gleevec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for gastrointestinal stromal Read the rest of this entry »

The Food and Drug Administration approved Watson Pharmaceuticals Inc.'s generic version of the nicotine gum Nicorette, the company said Wednesday, and Watson plans to start selling the mint-flavored gum in early January.
Watson said the FDA approved its over-the-counter nicotine polacrilex gum in 2 mg and 4 mg strengths. Nicorette is made by British drug maker GlaxoSmithKline PLC, and sold by Johnson & Johnson Healthcare. The FDA approved Nicorette Read the rest of this entry »

has received approval from the Food and Drug Administration to begin a clinical trial of a product candidate to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that affects mainly young children.
Palo Alto-based StemCells (NASDAQ: STEM) designed the Phase 1 trial to evaluate the safety and efficacy of its HuCNS-SC product candidate cells as a treatment for PMD. Currently, there are no approved treatments for this disease, the company Read the rest of this entry »

(Adds analysts' comments, updates stock movement)
Dec 9 (Reuters) - Targanta Therapeutics Corp said U.S. health regulators declined the approval of its antibiotic and raised questions about the safety of the drug, triggering a 63 percent drop in its shares.
The U.S. Food and Drug Administration asked the company to perform an additional clinical study to show efficacy and safety of the drug, oritavancin, for treating complicated skin and skin Read the rest of this entry »

Safe Harbor Act: This release includes forward-looking statements
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 that involves risks and uncertainties
including, but not limited to, the impact of competitive products,
the ability to meet customer demand, the ability to manage growth,
acquisitions of technology, equipment, or human resources, the effect
of economic business conditions, and Read the rest of this entry »

Shares in Malaysia-based sweetener group PureCircle (PURE.L:
,
,
) jump nearly 14
percent as the company says it receives U.S. approval for its natural no-calorie
sweetener Reb-A.
"This is a fantastic result for PureCircle. The fact that the FDA (Food and
Drug Administration) has sanctioned Reb A for use increases the possibility that
it will also be sanctioned in Europe - another key market," says Ambrian in a
note.
"We anticipate that Read the rest of this entry »

Oct 20 2008, 12:23 PM EST
Teva Pharmaceutical Industries Ltd. (
) announced today
that the U.S. Food and Drug Administration has granted approval for
the Company's Abbreviated New Drug Application (ANDA) for Fentanyl
Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100
mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic
pain treatment Duragesic(R). Shipment of this product has commenced.
Total annual sales of this Read the rest of this entry »

Byetta (exenatide) is an analogue of glucagon-like peptide (GLP-1) derived from the saliva of a Gila monster. Injected twice daily an hour before meals, the drug mimics GLP-1 and enhances insulin secretion, improving Glycemic control in Type 2 diabetics. To date, over a million people have taken Byetta, and now, more than three years after the FDA approved Byetta in April 2005, reports have surfaced that Byetta is linked with necrotizing pancreatitis, Read the rest of this entry »

WASHINGTON -- The Food and Drug Administration granted wider approval to Prezista, a
HIV drug, by allowing the medication to be given to newly diagnosed patients, the company said Wednesday.
Prezista, a protease inhibitor aimed at blocking HIV replication, is designed to be used in combination with
' Norvir.
Prezista was first approved in 2006 for use in patients who were resistant to other drugs. At the time, Prezista was also granted tentative Read the rest of this entry »