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FDA approves first epoetin alfa biosimilar for the treatment of anemia worldpharmanews
May 23, 2018
The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy,
FDA approves novel preventive treatment for migraine worldpharmanews
May 23, 2018
The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults.
FDA Grants Harmony Breakthrough Therapy & Fast Track Designations contractpharma
May 22, 2018
Harmony Biosciences has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA).
US FDA completes inspection of Lupin’s Nagpur plant financialexpress
May 21, 2018
Lupin said the US health regulator has completed inspection of its Nagpur facility without making any observations.
Goran Pharma’s Gujarat facility receives US FDA warning for CGMP Violations financialexpress
May 21, 2018
Goran Pharma’s Sihor facility in Gujarat has received a US FDA warning letter. Reportedly, deviations from current good manufacturing practices (CGMPs),
Jubilant Life gets US FDA nod for heart drug financialexpress
May 21, 2018
Jubilant Life Sciences has received the final approval from US FDA for its generic Niacin extended-release tablets used for controlling cholesterol levels.
Granules gets US FDA nod for postpartum haemorrhage prevention drug financialexpress
May 21, 2018
Granules India said its subsidiary has received approval from the US health regulator for Methylergonovine tablets, used for the prevention and control of postpartum haemorrhage.
Divis Labs Choutuppal Unit-1 gets US FDA nod financialexpress
May 21, 2018
Divis Laboratories Choutuppal Unit 1 in Telangana was recently undergone an US FDA inspection.
Indoco facilities bag US FDA nod financialexpress
May 21, 2018
Indoco Remedies announced the successful completion of US FDA inspection at its API manufacturing facilities at Patalganga and Rabale, Navi Mumbai.
FDA approves first non-opioid treatment for opioid withdrawal biospectrumasia
May 18, 2018
Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.

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