Watson files application with FDA for generic YAZ
CORONA, Calif. Watson Pharmaceuticals is looking to produce a generic version of a popular oral contraceptive, the company said Wednesday.
The specialty pharma company has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market a generic version of YAZ tablets (drosperinone and ethinyl estradiol) prior to the expiration of patents owned by Bayer.
Bayer filed suit against Watson on Monday in the U.S. District Court’s Nevada circuit, seeking to prevent Watson from commercializing its product prior to the expiration of patents.
Bayer’s suit was filed under the provisions of the Hatch Waxman Act, resulting in a postponement of FDA approval of Watson’s ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner.
Sales of YAZ for 2006 were approximately $660 million, according to Bayer data.
Mass. court levies combined $13.6 million against AstraZeneca, Bristol-Myers Squibb
BOSTON A federal court in Massachusetts entered $12.9 million in damages against AstraZeneca and $695,594 against Bristol-Myers Squibb for the state’s class action members in a suit related to marketing the spread of certain drugs, according to law firms.
The judge, Patti B. Saris, found that AstraZeneca marketed the spread on its Zoladex drug, which is used to treat prostate cancer, selling it based on its profitability to doctors’ offices. She also found that less than 10 percent of Bristol-Myers Squibb’s sales were made within 5 percent of its list price, according to DowJones.
AstraZeneca and Bristol-Myers Squibb intend to appeal the ruling, which covers Massachusetts’s class-action participants.
Eli Lilly’s depression care program receives certification
INDIANAPOLIS Eli Lilly has received Program Design Certification from the National Committee for Quality Assurance for its Tools that Empower Depression Care Management Program.
Tools that Empower Depression Care Management Program is designed for managed care organizations to assist in further driving the standard of patient care around major depressive disorder. It helps identify members with major depressive disorder and offers educational resources to support treatment.
“Tools that Empower is part of Lilly’s commitment to our customers to help reduce patient risk and create an environment of continuous improvement for patient care,” said Jack Bailey, vice president, Lilly’s Business to Business division. “The NCQA certification validates the helpful tools provided by the program.”