Generics

BASKING RIDGE, N.J. — Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.

The MyEpiPen app is available for the Apple iPhone, iPod Touch and iPad, and allows individuals, parents, guardians and others to create and share profiles of severe allergies with friends, family, teachers, school nurses, babysitters and others. Other features include an instructional video, user guide and others.

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

SAN FRANCISCO — Though it plans to announce its fiscal year 2010 results next month, Watson Pharmaceuticals offered a peak at some preliminary numbers at the 29th annual J.P. Morgan Healthcare Conference Wednesday.

Watson said that based on a review of results for last year, it expects to have earned revenues of more than $3.5 billion, a 25% increase over 2009.