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.
FDA accepts regulatory filing for Depomed drug
MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.
Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.
The FDA’s Reproductive Health Drugs Advisory Committee will discuss the drug at a meeting scheduled for March 2013. Advisory committees, which consist of experts convened by the FDA, issue recommendations of whether the agency should approve drugs. Their recommendations are not binding, but the agency usually follows them. The FDA is expected to decide whether or not to approve the drug in May 2013.