Zydus Cadila has received the final approval from the USFDA to market Zolmitriptan Tablets, 2.5 mg and 5 mg. It is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, and sensitivity to light/sound). It will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad. In line with this, the group now has 203 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Hospira Oncology Pvt. Ltd., a 50: 50 joint venture company between Zydus Cadila and Hospira Inc., USA (now part of Pfizer Group) has received an Establishment Inspection Report (EIR) from the USFDA which concluded that the inspection is “closed” and states that the inspection classification of this facility is ‘Voluntary Action Indicated’ (VAI). The manufacturing plant had completed the USFDA audit from 5th to 12th April 2018.
Dr. Reddy's Laboratories announces launch of Hydroxychloroquine Sulfate Tablets in U.S.
Dr. Reddy’s Laboratories Ltd. has announced the launch of Hydroxychloroquine Sulfate Tablets USP, 200 mg, a therapeutic equivalent generic version of Plaquenil® (hydroxychloroquine sulfate) Tablets, in the U.S. market, approved by the U.S. Food and Drug Administration (USFDA). The Plaquenil® brand and generic had U.S. sales of approximately $215 million MAT for the most recent twelve months ending in May 2018 according to IMS Health*. Dr. Reddy’s Hydroxychloroquine Sulfate Tablets are available in 200 mg tablets in the bottle count sizes of 100 and 500. Plaquenil® is a trademark of Concordia International Corp.