Medindia LOGIN REGISTER
Medindia

Orexigen Says Will Halt Obesity Drug Development as FDA Demands are Unreasonable

by Kathy Jones on Jun 4 2011 5:50 PM

California based pharmaceutical company Orexigen Therapeutics has announced that it will be stopping the development of its diet pill in the American market

 Orexigen Says Will Halt Obesity Drug Development as FDA Demands are Unreasonable
California based pharmaceutical company Orexigen Therapeutics has announced that it will be stopping the development of its diet pill in the American market citing “unprecedented” demands by the health regulators over the pill’s safety.
The company said that it will now be concentrating on getting the approval for its diet pill, known as Contrave and another drug candidate, Empatic, in other international markets.

The US Food and Drug Administration had refused to approve the drug back in February after concerns were raised that it could affect the heart.

Orexigen said that the FDA wanted it to conduct a large study looking into whether the drug actually affected the heart and the company said that the study would have unveiled information that was not necessary for its approval.

Source-Medindia


Advertisement