Mylan launches generic contraceptive
PITTSBURGH — Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.
Mylan announced the launch of norethindrone tablets in the 0.35 mg strength. The drug is a generic version of Micronor, made by J&J subsidiary Janssen Pharmaceuticals. A company partnering with Mylan on the drug, Famy Care, received approval from the Food and Drug Administration for the drug.
Various versions of the drug had sales of about $57.2 million during the 12-month period that ended in March, according to IMS Health.
CVS Caremark Charity Classic golf tournament held in R.I.
WOONSOCKET, R.I. — The CVS Caremark Charity Classic kicked off June 23, bringing together 20 of the world’s top golfers who team up to help raise millions of dollars for area charities.
The event, held at the Rhode Island Country Club in Barrington, R.I., ran from June 23 to 25.
(CVS Caremark president and CEO Larry Merlo (center) with the LPGA’s Lexi Thompson and local news anchor at WPRI-TV, Patrick Little)
Tournament week began with the Pepsi Pro-Am on June 23, followed by the two-day tournament on June 24 and 25. Golfers headlining the Pro-Am event included tournament co-host Billy Andrade as well as main field pro Lexi Thompson.
Since 1999, the CVS Caremark Charity Classic has driven more than $16 million to charities around the region, providing funding for a variety of programs serving children, families and people in transition throughout Southeastern New England.
Drug for nephropathic cystinosis receives seven years’ exclusivity
NOVATO, Calif. — The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.
Raptor said the FDA granted it orphan product exclusivity for Procysbi (cysteamine bitartrate) delayed-release capsules for managing nephropathic cystinosis in patients aged 6 and older. Nephropathic cystinosis is a rare, life-threatening lysosomal storage disorder that causes toxic accumulation of an amino acid called cystine in the body’s cells, tissues and organs, leading to progressive and irreversible tissue damage and organ failure. An estimated 500 patients in the United States have the disease.
"This decision was the outcome of a productive and cooperative process with the FDA," Raptor chief business officer Thomas Daley said. "We believe the issuance of orphan drug exclusivity highlights an appreciation that Procysbi is an important new therapeutic option for nephropathic cystinosis patients."
The drug was approved in April, and the exclusivity period lasts for seven years. Under normal circumstances, the FDA gives a pharmaceutical drug an exclusivity period of five years, meaning generic drug makers must wait until the exclusivity period has expired before they may file for approval of a generic version.