Generics

HERTFORDSHIRE, England and PITTSBURGH — Mylan launched two new product Friday, introducing its generic of Novartis’ Reclast (zoledronic  acid) injection and Teva’s Azilect (rasagiline) tablets, both of which were recently approved by the Food and Drug Administration.

The Reclast generic is distributed in 5 mg/100 ml single dose vials, and is indicated to treat Paget’s disease of the bone in men and women. The drug had U.S. sales of approximately $22.1 million for the 12 months ended March 31, according to QuintilesIMS data.

TOKYO and MINNEAPOLIS — Sawai Pharmaceuticals and Upsher-Smith Laboratories announced Thursday the completion of Sawai’s acquisition of Upsher-Smith’s generics business.

The acquisition gives Sawai a foothold in the U.S. generics market, and the company will retain Rusty Field as the president of the company, adding the role of CEO to his duties. Sawai said that it intends to retain operations in Minnesota and Colorado.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced its approval of the first generic versions of Strattera (atomoxetine), a treatment for attention-deficit/hyperactivity disorder in children and adults.

Apotex, Aurobindo, Teva and Glenmark all earned approval from the regulatory agency to market the drug in multiple strengths.

WASHINGTON — Food and Drug Commissioner Dr. Scott Gottlieb laid out a preliminary vision of his plans to bring more generics to market at a hearing before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies on May 25. The hearing was held as part of several others that sought input from administration officials about President Donald Trump’s proposed budget.

ANNAPOLIS, Md. — A bill passed by Maryland’s state legislature became law without Gov. Larry Hogan’s signature late last week. The bill is designed to allow the state’s attorney general to take action against drug makers that raise prices of a drug beyond a certain threshold, and generally seeks to increase transparency in how generics are priced, including itemizing the components of the cost of producing a generic.

NEW YORK — Pfizer on Thursday announced the Food and Drug Administration Oncologic Drugs Advisory Committee recommended approval of the company’s proposed Epogen and Procrit (epoetin alfa) biosimilar across all indications. According to Pfizer, this marks the first time a biosimilar erythropoiesis-stimulating agent has been recommended for approval by a U.S. FDA Advisory Committee.