Product Updates
- Mon, 6/28/10 - 2:42pm
- 0 Comments
- 549 reads
News
New Treatment for Late-Onset Pompe Disease
The FDA approved alglucosidase alfa (Lumizyme) for patients ≥8 years of age with late-onset, noninfantile Pompe disease, a rare genetic disorder. Alglucosidase alfa, marketed by Genzyme Corporation, is believed to work by replacing the deficient acid alpha-glucosidase necessary for proper muscle functioning, thereby reducing the accumulated glycogen in heart and skeletal muscle cells.
Alglucosidase alfa is being approved with a Risk Evaluation and Mitigation Strategy. It will only
Product News
- Mon, 5/24/10 - 1:30pm
- 0 Comments
- 773 reads
Product News
New Combination Oral Contraceptive
The US Food and Drug Administration (FDA) has approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at 4 times throughout each 28-day treatment cycle. The product is manufactured by Ba
Product News
- Wed, 5/5/10 - 11:07am
- 0 Comments
- 400 reads
FDA News
Injection Treats Small Varicose Veins
The FDA has approved polidocanol (Asclera) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins. Polid-
ocanol is distributed by BioForm Medical Inc and manufactured by Chemische Fabrik Kreussler & Co.
The product is approved to close spider veins (tiny varicose veins <1 mm in diameter) and reticular veins (those that are 1-3 mm in diameter). Polidocanol acts by damaging the cell lining of blood vessels. This causes the bl
Product Updates
- Thu, 3/18/10 - 3:42pm
- 0 Comments
- 638 reads
New Drug for Gaucher Disease
The FDA has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. VPRIV is manufactured by Shire Human Genetic Therapies Inc.
Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. VPRIV provides long-term enzyme replacement therapy for Type 1 Gaucher disease, the most common form of the genetic disorder. It is an alternative to imiglucerase (Cerezyme), another enzyme replacement therapy. According to the
Product News
- Thu, 1/28/10 - 3:14pm
- 0 Comments
- 699 reads
New Drug for Rheumatoid Arthritis
The FDA has approved tocilizumab (Actemra) for the treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis. Recommendations for the use of tocilizumab is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastr
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