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District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women
NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step.
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Dr. Reddy's launches generic osteoporosis drug
HYDERABAD, India — Dr. Reddy's Labs has launched zoledronic acid injection in the 5 mg-per-100-mL strength, the Indian generic drug maker Thursday.
The drug, launched following its approval by the Food and Drug Administration, is a generic version of Novartis' Reclast and is used to treat osteoporosis. Reclast had sales of $355 million during the 12-month period that ended in February, according to IMS Health.