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FDA approves 2 more dosage strengths of Impax’s Focalin XR generic
SILVER SPRING, Md. — The Food and Drug Administration has approved two additional dosage strengths for Impax Laboratories’ generic of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules.
The approval was given for 25- and 35-mg dosage strengths of the drug, and Impax said it has immediately begun commercialization activities. The approval adds to the 5-, 10-, 15-, 20- and 30-mg capsules the company has previously launched of the generic.
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Lupin intros generic Vigamox
MUMBAI and BALTIMORE — Lupin on Wednesday announced the launch of its generic of Vigamox (moxifloxacin hydrochloride, 0.5%) ophthalmic solution. The drug is indicated to treat bacterial conjunctivitis caused by susceptible strains of the organisms.
Vigamox had U.S. sales of approximately $267.9 million, according to Quintiles IMS data for the 12 months ended March 2017.