FDA approves subcutaneous formulation of Orencia
PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.
The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.
“Physicians now have a new option of a non anti-TNF, with a different mechanism of action, when administering a biologic in a subcutaneous formulation,” Stanford University Medical Center professor Mark Genovese said, referring to anti-tumor necrosis factor medications, biotech drugs that combat RA and other autoimmune disorders, by counteracting a protein that the body uses to combat tumors but also is involved in autoimmune diseases.
Lannett receives FDA approval for generic Ionamin
PHILADELPHIA — The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.
Lannett said that the FDA approved its abbreviated new drug application for phentermine resin extended-release capsules in the 15-mg and 30-mg strengths. The drug, which is equivalent to UCB’s Ionamin, will be sold in bariatric clinics.
Lannett’s wholly owned pain management subsidiary, Cody Labs, will produce the active pharmaceutical ingredient for this product. The drug is indicated in the management of exogenous obesity, a form of obesity caused by excessive food intake.
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.