Pfizer Inc. will appear on Monday presenting its Fablyn osteoporosis drug on the market. Still, medical experts and the Food and Drug Administration will have to approve the drug by submitting it to various tests. This will be the third attempt of the drug to go out on the market and its approval stands to be very important for the pharmaceutical company.

Documents released before the meeting showed that the FDA said that patients taking Fablyn were at lower risk to develop spine fractures when comparing the medicine to a regular placebo. Still, the agency stated that there are more risks to die if taking the Fablyn than taking the placebo.

Pfizer responded that the number of deaths "appears to be due to an unusually low mortality rate for the placebo group" during the study period. The FDA added that the patients taking the Fablyn for Pfizer are more likely to develop blood clots.

Fablyn has been made to treat osteoporosis in postmenopausal women and it works like the hormone estrogen in some parts of the body and not in other parts. These kinds of drugs are named selective receptor modulators, but don’t have the side effects associated with estrogen.

The first disapproval of the Fablyn happened in 2005, when the drug was called Oporia and was released for prevention of the osteoporosis. In 2006, the FDA again rejected the drug for a second indication of vagional atrophy, because both drugs caused an increased risk of endometrial cancer.

Pfizer Inc. looked again at its drug and made it better. It released the drug under the name of Fablyn and it put it on the market for treating osteoporosis.
If the drug it’s approved, this will become a blockbuster with peak sales of $1 billion a year, but it won’t approach Lipitor, which earned $13 billion in 2007.