logo
Plus   Neg
Share
Email

Medicines360: FDA Approves Extended Duration Of Use For LILETTA

Medicines360 and Allergan plc (AGN) announced the U.S. FDA has approved Medicines360's Supplemental New Drug Application to extend the duration of use of LILETTA 52 mg for the prevention of pregnancy for up to six years. LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy. Medicines360 noted that the approval marks the longest approved duration of use of any hormonal intrauterine devices.

Medicines360 received initial approval of LILETTA in 2015. Since then, Medicines360 and Allergan have continued to invest in the product. LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
New York Attorney General Letitia James has fled a lawsuit against Vyera Pharmaceuticals and two of its former CEOs, including imprisoned 'Pharma Bro' Martin Shkreli, for illegally monopolizing a life-saving drug Daraprim. The lawsuit seeks a lifetime ban on Shkreli and his business partner Kevin Mulleady working in the pharmaceutical industry. Graco Inc. (GGG) shares were climbing more than 7 percent in morning trade. Monday after market close, the company had reported a surge in the fourth-quarter earnings to $84.8 million from $73.7 million in the prior year. Earnings per share surpassed analysts' estimates. Sales were up 1 percent to $412.3... Strategy of getting multiple indication approvals for the same drug seems to be paying off for AstraZeneca PLC (AZN), in terms of higher likelihood of approval and improved sales. Besides, the company is realizing value from non-core, mature brands to invest in new drugs, which also seems to be working in its favor.
Follow RTT
>