Barr Pharmaceuticals and its subsidiary Pliva have received final approval from the FDA for its Abbreviated New Drug Application (ANDA) to manufacture and market azithromycin for injection, 500 mg vial, the generic version of Pfizer’s Zithromax IV (azithromycin for injection). The company intends to launch its product during the first quarter of 2007. The company's azithromycin for injection, 500 mg vial will compete in a market that had total U.S. sales of approximately $75 million, based on IMS data for the 12-month period ending November 2006.
Berlex, a US affiliate of Bayer Schering Pharma of Germany, announced that the FDA has approved a new indication for Yaz (drospirenone/ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control.
Wyeth’s Pristiq antidepressant received conditional FDA approval, delayed by the agency due to problems at the drug’s manufacturing site in Guayama, Puerto Rico. The manufacturing site is awaiting final inspection by the FDA, however no firm timetable has been issued. “We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments,” Joseph Mahady, president of the company’s Wyeth Pharmaceuticals Unit, said in a statement. Concerns about quality control at Wyeth’s Guayama plant also arose in May after the FDA criticized the company for lapses involving at least a dozen drugs manufactured there. In 2000, Wyeth recalled more than 4 million capsules of generic painkiller Lodine made at the same Guayama plant. Wyeth is hoping that Pristiq will be able to replace Effexor, the world’s top-selling antidepressant with $3.5 billion in 2005 sales. Effexor loses patent protection in 2010. Wyeth said Pristiq may generate $2 billion annually if approved as an antidepressant and a menopause treatment, a secondary use the FDA may rule on in April.