Tuesday, March 10, 2009

Osteoporosis and Dangerous Drugs

Here's an osteoporosis drug that isn't approved yet and has been trying for the past several years to be approved.

Pfizer submitted the current application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.

This doesn't sound convincing to me.

Osteoporosis drugs are not without terrible side effects and drugs taken for gastric ulcers can cause osteoporosis.

Friday, March 6, 2009

A new pill called Kapidex, for chronic heartburn caused when excess stomach acid backs up into the esophagus, was cleared by the Food and Drug Administration.

Kapidex is a new version of Prevacid.

The new formulation releases the drug in two separate stages in order to spread out the dose more evenly.

Prevacid loses its proprietary patent in November 2009. Prevacid and drugs of its genre (proton pump inhibitors) are the best selling prescribed drugs. (Blogger’s note: Americans must have a lot of heartburn. Is there no remedy without drugs?)

Regulators took three months longer than scheduled to decide whether to approve the new medicine, dexlansoprazole. (Blogger’s note: Why?)

Tuesday, March 3, 2009

Generic Relief for Peptic Ulcer Sufferers

Mylan Inc. received final FDA approval for a generic version of the heartburn drug Prilosec.

The U.S. Food and Drug Administration approved an abbreviated new drug application for omeprazole delayed-release capsules, 40 mg.

The capsules are approved for the treatment of peptic ulcers and gastroesophageal reflux disease.

Prilosec is made by AstraZeneca PLC. Prilosec has serious side effects.

Mylan's shares went up.

Sunday, March 1, 2009

Generic Prilosec Hits the Market

The Food and Drug Administration has approved Impax Laboratories Inc.’s Abbreviated New Drug Application for a generic version of Prilosec.

Prilosec is marketed by AstraZeneca for the treatment of duodenal/gastric ulcers and gastro-esophageal reflux disease (GERD).

The new approval is for 40-mg delayed-release capsules.

Prilosec is not without serious side effects.