Content about Pharmaceutics

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

JERUSALEM — Teva Pharmaceutical Industries is set to market a generic version of an HIV treatment, the drug maker announced Thursday.

Teva said it will launch generic Combivir tablets (lamivudine and zidovudine) and is eligible for a 180-day period of marketing exclusivity, according to the Food and Drug Administration. The drug maker is expected to ship the drug in fourth quarter 2011, per terms of a settlement agreement between Teva, Glaxo Group and ViiV Healthcare.

INDIANAPOLIS — Drug maker Eli Lilly is partnering with two private investor groups to form a new biotech company based in central Indiana, the company said Monday.

Lilly signed a deal with Care Capital and NovaQuest Capital to establish BioCritica, a privately held biotechnology company that will focus on continued U.S. development and commercialization of the severe sepsis treatment Xigris (drotrecogin alfa [activated]). The new company also will expand its portfolio of critical care medicines for hospitals.

BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.

Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.

SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


SILVER SPRING, Md. — A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

NEW YORK — Japan-based Takeda Pharmaceutical may acquire Switzerland’s Nycomed for $12 billion, according to published reports.

Reuters reported Thursday that Takeda was in talks to buy Nycomed in order to expand its presence in the European market. Most of Takeda’s business is in Asia and the United States.

Nycomed makes treatments for such diseases as chronic obstructive pulmonary disease, chronic pain, osteoporosis and others.

MADISON, Miss. — Cypress Pharmaceuticals has launched a generic version of an eye care drug made by Boehringer Ingelheim and marketed by Allergan, the company said.

Cypress announced the launch of epinastine hydrochloride ophthalmic solution 0.05%, a generic version of Elestat; BI owns the trademark to Elestat and licenses rights to the drug to Allergan. Elestat is used to relieve itching of the eyes resulting from allergic conjunctivitis.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

JERUSALEM — Cephalon has another suitor in the form of the world’s largest generic drug company.

Teva Pharmaceutical Industries said Monday that it would buy Frazer, Pa.-based Cephalon for $6.8 billion, undercutting efforts by Valeant Pharmaceuticals International, which had offered $5.7 billion in March.

The boards of both companies have agreed to the acquisition, equal to $81.50 per share. Cephalon previously had turned down Valeant’s offer, prompting the Mississauga, Ontario-based company to take its case directly to Cephalon’s shareholders.

CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.