FDA approves first drug for eye condition
SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.
The agency announced the approval of Jetrea (ocriplasmin), made by Iselin, N.J.-based ThromboGenics. The drug is used to treat symptomatic vitreomacular adhesion.
VMA contributes to eye problems if the vitreous, the jelly in the center of the eye, moves away from the macula, the part responsible for reading vision, leading to damage to the macula due to tugging or pulling.
Jetrea is an enzyme that breaks down proteins in the eye responsible for VMA, allowing better separation between the vitreous and macula and reducing the chances that tugging will occur, the FDA said.
FDA approves generic Lupin contraceptive
MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.
Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.
The drug is a generic version of Teva’s branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.
Bristol-Myers Squibb skin cancer drug wins Prix Galien USA Prize
PRINCETON, N.J. — A cancer drug made by Bristol-Myers Squibb has received an award from Galien Foundation, the drug maker said Wednesday.
The company said Yervoy (ipilimumab) received the 2012 Prix Galien USA Prize in the Best Biotechnology Product category. Yervoy — used to treat melanoma that has spread to other parts of the body, known as metastasis — is the first new drug for melanoma that is metastatic or can’t be removed through surgery in more than a decade.
The selection committee for the ceremony includes several Nobel Laureates, and the drug has been shortlisted for the Prix Galien Prize in Germany, Bristol-Myers Squibb said.