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SunGen Pharma Receives Sixth ANDA Approval from FDA

Methylprednisolone approved for treatment of arthritis, allergic reactions, and immune system disorders

By: Cassandra Gervolino

SunGen Pharma has received its sixth ANDA approval from the FDA for Methylprednisolone tablets, 4 mg.
 
This drug product is a corticosteroid used to treat conditions including arthritis, allergic reactions, and immune system disorders, as well as dermatologic, ophthalmic, respiratory, and gastrointestinal diseases. Methylprednisolone tablets had total U.S. sales of $93 million for 1Q19, and $113 million and $124 million, respectively, for 2018 and 2017 according to IQVIA.
 
“These approvals represent one of many products being developed or co-developed by our company and with our partners around the world,” said Dr. Isaac Liu, Co-Founder and Co-CEO of the company.  “This is the sixth approval for SunGen. Our strong development capabilities are further supported by the short timeline in which US FDA has approved our dossiers.”

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