Content about Pharmacology

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

Walgreens and Alliance Boots entered into a 10-year contract with wholesaler AmerisourceBergen on sourcing pharmaceuticals last week. But that's not all. Besides the long-term contract, Walgreens and Alliance Boots will have the option on a potential 23% equity stake in ABC in three years. 

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

WAUKESHA, Wis. — Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

HRG said the service, Rx Top Sellers, would provide data on the top 200, 500, 750 or 1,000 prescriptions and include cash median prices that are charged by food-drug retailers and independent pharmacies, as well as mass merchandise retailers.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

DEERFIELD, Ill. — Walgreens will no longer source branded prescription medicines directly from suppliers beginning in September, the Chicago-based retailer announced Tuesday as part of a significant partnership between Walgreens, Alliance Boots and AmerisourceBergen that includes Walgreens and Alliance Boots potentially taking a 7% stake in the Pennsylvania wholesaler. Walgreens will begin sourcing generic medicines from AmerisourceBergen beginning in the calendar year 2014.  

SANTA ANA, Calif. — Robinson Pharma last week introduced its Unique IS-2 Probiotic Softgel in collaboration with B&D Nutritional Ingredients and Unique Biotech USA. The new product is a shelf-stable, guaranteed-yield probiotic softgel that delivers the Unique IS-2 Bacillus coagulans strain, a trademarked bacterium which has demonstrated high resistance to extreme temperature and humidity.

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.