Content about Generics

PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie's AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.

HYDERABAD, India — Dr. Reddy's has launched a drug for treating acne, the company said Friday.

The Indian generic drug maker announced the launch of Zenatane (isotretinoin) capsules in the 20-mg and 40-mg strengths. The drug is a therapeutically equivalent generic version of Roche's Accutane. The Food and Drug Administration also approved the drug in the 10-mg strength.

Various versions of the drug had sales of about $309 million during the 12-month period that ended in January, according to IMS Health.

BOULDER, Colo. — Pharmaca Integrative Pharmacy on Thursday expanded its immunization offering to include travel vaccinations along with a comprehensive list of health services related to traveling abroad. 

Pharmaca patients can now schedule an appointment for any of the following vaccinations: hepatitis A and B, tetanus, typhoid, meningitis, Tdap, yellow fever (though not in Colorado locations), varicella and rabies. Pharmaca still offers vaccinations for flu, shingles, whooping cough and pneumonia on a walk-in basis.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.

ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

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.

SCHAUMBURG, Ill. — Generic drug maker Sagent Pharmaceuticals has appointed James Hussey as its president, the company said.

Sagent said the board of directors' appointment of Hussey, 53, would be effective Monday. Hussey will be responsible for the company's commercial operations, including development, regulatory affairs, supply chain activities, sales, marketing and human resources.

JERUSALEM — Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

Teva announced the appointment of Ivana Magovčević-Liebisch as SVP and head of corporate business development, effective April 1. Magovčević-Liebisch served as EVP and COO for Dyax, a Burlington, Mass.-based drug company.

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.

EDMONTON, Alberta — A plan to significantly reduce generic drug prices in Alberta has drawn criticism from pharmacists in the Canadian province.

The Alberta Pharmacists' Association said it was "shocked" in response to the provincial government's 2013 budget, which reduces generic drug prices from 35% to 18% of branded drug prices, effective May 1. Over the past two years, prices have been reduced from 75% to 35%, but the RxA said it supported the government in those cases.

WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.