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New & Approved: Levoxyl * Campath.(for the treatment of hypothyroidism)
Levoxyl
(levothyroxine sodium, King Pharmaceuticals)
A synthetic thyroid hormone for treating hypothyroidism and suppressing thyroid-stimulating hormone. This is the second thyroid hormone product approved by the Food and Drug Administration under a 1997 requirement that manufacturers of all marketed levothyroxine products file new drug applications by Aug. 14, 2001, These products were available before 1962, so they were never formally approved and did not undergo a full review.
* Recommended Dosage: Available in tablets ranging in strength from 25 [mirco]g to 300 [mirco]g.
* Special Considerations: Side effects of levothyroxine "are usually due to over-dosage and include, nervousness, weight loss, tachycardia, irritability, and anxiety," the FDA stated in August 2000 in approving Unithroid, the first such product approved under the new requirements.
* Comment: The approval establishes that the FDA considers Levoxyl effective and in compliance with standards for manufacturing, purity, potency and stability. Product recalls related to problems with stability and potency led to the 1997 FDA requirement. The products of companies that fail to meet the Aug. 15 deadline will be "subject to regulatory action as an unapproved drug," according to the FDA.
More than 70 million prescriptions for synthetic thyroid replacement drugs were dispensed last year, making such drugs the eighth most commonly dispensed prescription drug category in 2000, according to IMS America, a pharmaceutical market research firm. More than 60% of those prescriptions were for Synthroid, the third most commonly dispensed drug in 2000.
- U.S. FDA Approves New Treatment, Campath -- Alemtuzumab -- Humanized Monoclonal...
- Press release article from: Business Wire May 8, 2001 700+ words
...and Drug Administration (FDA) late yesterday cleared Campath(R) (alemtuzumab) humanized...reported in patients receiving Campath. Summary of Efficacy and Safety Data In evaluating Campath, the FDA reviewed efficacy data from...
- FDA APPROVES ILEX, MILLENNIUM ANTIBODY CAMPATH FOR LEUKEMIA.
- Magazine article from: BIOWORLD Today Coghill, Kim May 9, 2001 700+ words
...Pharmaceuticals Inc. received FDA approval to market Campath, a leukemia drug expected...cells. In evaluating Campath, the FDA reviewed efficacy data...respectively. The Campath biologics license application...was submitted to the FDA in December 1999...
- M&I Partners' Response Concerning CAMPATH Accepted by FDA.
- Press release article from: Business Wire April 6, 2001 700+ words
...Application (BLA) for CAMPATH(R) (alemtuzumab...its letter, the FDA stated that it accepted...19, 2001." The CAMPATH(R) investigational...designation from the FDA and has been undergoing...working with the FDA to finalize package...clinical study of CAMPATH(R). CAMPATH...
- Millennium & ILEX Partners Receive Complete Response Letter From FDA for...
- Press release article from: Business Wire February 21, 2001 700+ words
...submitted a BLA for CAMPATH(R) to the FDA in December 1999...February 2000. CAMPATH(R) received...designation from the FDA and has been undergoing...under PDUFA. The FDA also granted orphan drug designation to CAMPATH(R). On Dec...
- FDA Completes Initial Review of Millennium & ILEX Partners' BLA Submission for...
- Press release article from: Business Wire June 26, 2000 700+ words
...complete review of the Campath(R) application satisfied FDA's performance goal...monoclonal antibody Campath(R) with the FDA in December 1999...under PDUFA. The FDA also granted orphan drug designation to Campath(R). In Europe...
- Genzyme names new Head of Product Development for Campath and Merck gets FDA OK...
- Press release article from: M2 Presswire January 13, 2006 700+ words
...Product Development for Campath and Merck gets FDA OK for widened use of...of the oncology drug Campath. Murdock is the new...commercialization of Campath. Biotechnology company...help to guide us through FDA applications and clinical...
- FDA approves Campath as single agent for B-CLL.
- Newspaper article from: Pharma Marketletter October 1, 2007 700+ words
...Application for the anticancer agent Campath (alemtuzumab). The agency...adult lymphocytic leukemia. The FDA's decision is based on data...The results showed that Campath increased progression-free...addition, patients treated with Campath exhibited higher overall and...
- FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment...
- Press release article from: PR Newswire September 20, 2007 700+ words
...Administration (FDA) has approved a...application (sBLA) for Campath(R) (alemtuzumab...leukemia (B-CLL). Campath was initially approved...regulations and the FDA has determined that...type of leukemia." Campath works in an entirely...antibody approved by the FDA for the treatment...
