Regulatory and Washington

NEW YORK — Two companies have settled with Teva over the latter's efforts to launch a generic version of an emergency treatment for allergic reactions.

Under the agreement, involving Mylan and Pfizer's Meridian Medical Technologies subsidiary, Teva will be allowed to launch a generic version of EpiPen (epinephrine) auto-injector in June 2015, assuming it wins approval from the Food and Drug Administration. Mylan Specialty markets the EpiPen, which Meridian manufactures.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

WASHINGTON — Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

PALM BEACH, Fla. — On the final evening of the National Association of Chain Drug Stores' annual meeting in Palm Beach, Fla., the organization honored two industry leaders with chain pharmacy's highest honors.

NACDS recognized Andrew Giancamilli, former Rexall Pharma Plus CEO and past NACDS chairman, with the Sheldon W. Fantle Lifetime Achievement Award. M. Jerome Brown, former Unilever VP industry and customer development, received the Robert B. Begley Award.