Similarly, Vivus/Eisai's Qsymia
was also issued a CRL, which requested further details regarding the clinical label, Risk Evaluation and Mitigation Strategy, safety update, and drug scheduling data.
, however, topiramate is contraindicated in pregnancy and is a pregnancy category X, because its use "can cause fetal harm, and weight loss offers no potential benefit to a pregnant woman," the labeling states.
Those drugs are Qsymia
, which is sold by Vivus, and Belviq, which is from Arena Pharmaceuticals and Eisai.
Currently only three drugs, Orlistat, Lorcaserin and Qsymia
are approved by the Food and Drug Adminsitration (FDA) for the long term treatment of obesity (Adan, 2013).
Nearly a year after both prescription drugs were approved, Belviq and Qsymia
, are available.
Shares of VIVUS declined due to a slow launch of Qsymia
Similarly, last year FDA said women who want to use a new weight-loss drug, Qsymia
, need testing first to be sure they're not pregnant.
But Vivus, which sent out only 150 sales representatives to a target market of 25,000 doctors, is betting on slow, steady marketing of the Qsymia
drug to win over customers.
ScinoPharm supplies 15 to 20-tons of slimming drug API per year for Qsymia
, a new diet drug produced by Vivus, and the volume is expected to double by 2013.
According to the BBC, the FDA approved the use of Qsymia
for patients who are overweight or obese and have at least one other weight-related condition.
Utilizing its unique drug delivery capabilities, Catalent partnered with VIVUS during the development of Qsymia
, including pre-formulation and formulation, clinical supply and validation.
Two Additional US Patents Issued For Vivus' Qsymia
- EC Approves Kengrexal/Orbactiv/Raplixa 13.