Generics

NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.

The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.

The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.

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.

PRINCETON, N.J. — Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

Sandoz announced the launch of donepezil hydrochloride film-coated tablets and donepezil hydrochloride orally disintegrating tablets, which are generic versions of Eisai and Pfizer’s Aricept and Aricept ODT, respectively.

Donepezil hydrochloride film-coated and orally disintegrating tablets had sales of $2.3 billion in the 12-month period ended in March, according to IMS Health.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

ISSAQUAH, Wash. — Costco Wholesale EVP, CFO and director Richard Galanti told investors during the company’s third quarter 2011 earnings call last week that average prices in pharmacy probably would decline due to the introduction of generic versions of branded drugs.

“[The] only area where you are going to see some average price declines is probably in pharmacy where, and we've all read about it, there is some very well-known branded items that are going to become generic this coming year,” Galanti said.

HAWTHORNE, N.Y. — Taro realized a 21% increase in net sales for its first quarter, the drug maker said.

The company said it raked in net sales of $107.7 million, an increase of $18.7 million. Diluted earnings per share totaled 58 cents, compared with 21 cents in the prior-year period.

Operating income for Taro increased 84.4% to $33.4 million, or 31% of net sales, compared with $18.1 million, or 20.3% of net sales, in 2010.

During the period, Taro received three abbreviated new drug applications from the Food and Drug Administration.

PITTSBURGH — Generic drug maker Mylan plans to give one of its subsidiaries a new name, the company said.

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.