Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.
A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.
Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.
Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.
The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.
The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.
The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.
Clarinex (desloratadine), the next-generation prescription allergy remedy to the second-generation Claritin, is 1-of-3 blockbuster prescription medicines that may make the crossover from prescription-only to over-the-counter in the near future.
Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.
The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.
Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.
A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.
The regulatory waiting period standing between Bristol-Myers Squibb and its acquisition of drug maker Inhibitex has expired, giving Bristol the green light to buy the company.