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Bisphosphonate approved, but not being launched. (Convenient Dosing Sought).
The Food and Drug Administration has approved a daily formulation of ibandronate sodium for the treatment and prevention of postmenopausal osteoporosis, but the manufacturer has no immediate plans to launch the bisphosphonate until more convenient dosing regimens are approved.
The trade name of the drug, approved in a tablet formulation, is Boniva. The approval was for a daily dosing regimen, a less attractive dosing alternative to the other two bisphosphonates already on the market--alendronate (Fosamax) and risedronate (Actonel)--both of which are approved on a once-weekly dosing schedule.
An intermittent schedule of ibandronate has been reported to be effective in ...
- Keppra XR(TM) Offers Convenient Dosing For People With Partial Onset Seizures.
- Press release article from: PR Newswire November 5, 2008 700+ words
...information: UCB announced today that Keppra XR(TM) offers convenient dosing for people with epilepsy. Keppra XR(TM) was approved by the U.S. Food and Drug Administration (FDA) in September 2008 for use as an add-on to other antiepileptic...
- SMITHKLINE BEECHAM'S AUGMENTIN CLEARED IN U.S. FOR MORE CONVENIENT DOSING...
- Press release article from: PR Newswire February 12, 1996 700+ words
...regimen have also been filed with the U.S. Food and Drug Administration. SmithKline Beecham (NYSE: SBE, SBH) -- one of the...regimen have also been filed with the U.S. Food and Drug Administration; however, the currently approved pediatric regimen in...
- SMITHKLINE BEECHAM LAUNCHES AUGMENTIN(R) IN MORE CONVENIENT DOSING REGIMEN FOR...
- Press release article from: PR Newswire February 27, 1996 700+ words
PHILADELPHIA, Feb. 27 /PRNewswire/ -- SmithKline Beecham (SB) (NYSE: SBH, SBE) announced today the introduction of a new, more convenient adult dosing regimen of Augmentin (amoxicillin/clavulanate potassium), one of the most frequently used antibiotics for infections involving drug-resistant
- HYZAAR(R) 100-12.5 mg Offers A New Convenient Dosing Option Within The Losartan...
- Press release article from: Business Wire October 21, 2005 700+ words
WHITEHOUSE STATION, N.J. -- Merck & Co., Inc., today announced the availability of HYZAAR(R) 100-12.5 mg (losartan potassium/hydrochlorothiazide tablets), a new tablet that combines the once-daily efficacy of 100 mg COZAAR(R) (losartan potassium tablets) with a low-dose diuretic to provide
- SMITHKLINE BEECHAM'S AUGMENTIN(R) CLEARED IN U.S. IN MORE CONVENIENT DOSING...
- Press release article from: PR Newswire June 3, 1996 700+ words
Twice-A-Day Regimen and New Formulations Reduce the Most Troublesome Side Effect of Drug Widely Used in Fight Against Resistant Bacteria New Fruit Flavors, Too PHILADELPHIA, June 3 /PRNewswire/ -- SmithKline Beecham (SB) (NYSE: SBH) announced today that it has received U.S. marketing clearance for
- U.S. Food and Drug Administration Approves Supplemental New Drug Application...
- Press release article from: PR Newswire November 14, 2005 700+ words
- Data Supports Label Change for New More Convenient Dosing Regimen - LIBERTY CORNER, N.J., Nov. 14...Pharmaceuticals, Inc. announced today that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application...
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S....
- Press release article from: PR Newswire December 21, 2004 700+ words
...to the U.S. Food and Drug Administration (FDA) for dalbavancin...allow for more flexible and convenient dosing regimens than vancomycin...with the U.S. Food and Drug Administration for its lead products...
- NEW THERAPY FOR SHINGLES RELEASED FOR MARKETING BY U.S. FOOD & DRUG...
- Press release article from: PR Newswire October 12, 1995 700+ words
...has been released for marketing by the Food & Drug Administration. Valtrex(R) brand valacyclovir HC1, indicated for...managing patients with shingles, and it provides a more convenient dosing regimen when compared to Zovirax," said Karl Beutner...
Source: HighBeam Research, Bisphosphonate approved, but not being launched. (Convenient Dosing...