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FDA gives tentative approval to Aurobindo’s Tivicay generic
SILVER SPRING, Md. — The Food and Drug Administration has granted its tentative approval to Aurobindo Pharma for its generic of Tivicay (dolutegravir or DTG), making it the first approval for a generic of the HIV treatment recommended by the World Health Organization and the Centers for Disease Control and Prevention.Impax launches generic Metadate CD
HAYWARD, Calif. — Impax Laboratories on Thursday announced the launch of its generic of Metadate CD (methylphenidate hydrochloride) extended-release capsules.Impax’s generic will be available in 10-, 20-, 30-, 40-, 50- and 60-mg dosage strengths. The drug had U.S. sales of about $151 million for the 12 months ended July 2016, according to IMS Health data.