Trials & Filings

SunGen Pharma Receives Sixth ANDA Approval from FDA

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

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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