Strides Arcolab’s generic diabetes drug enters market
BANGALORE, India — The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.
The FDA approved acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a niche drug used to treat Type 2 diabetes, Strides said.
Acarbose tablets have sales of about $21 million, according to IMS Health.
Human antibody may protect against all influenza A viruses
NEW YORK — Researchers have found a human antibody that may be able to protect against all influenza A viruses, according to published reports.
The antibody, FI6, could lead to the development of a universal flu vaccine because it targets groups 1 and 2, the two main groups of the influenza A virus. Previously, researchers had not been able to find an antibody that worked against both groups.
The researchers have found the antibody effective in mice and ferrets, according to the reports.
Teva launches authorized generic of Seasonique
JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.
Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).
The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.
An authorized generic is a branded drug sold in generic-like form at a reduced price, usually through a third-party company. Authorized generics provide a way for a branded drug’s manufacturer to compete with the generic manufacturer on price during the legally mandated six-month market exclusivity period, in which the first company to file for generic approval with the Food and Drug Administration can compete directly with the branded company without any additional generic competition.
Seasonique had sales of about $110 million during the 12-month period ended in April, according to IMS Health.