OYST - Oyster Point says impurities not a concern in its varenicline nasal spray

Oyster Point Pharma (OYST) has not observed any measurable impurities in its OC-01 (varenicline) nasal spray following announcement that an unrelated manufacturer of varenicline oral tablets has suspended distribution due to impurities discovered in one or more lots of its product.Oyster Point Pharma is developing OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease.The company currently sources OC-01 (varenicline) nasal spray active pharmaceutical ingredient ((API)), varenicline tartrate, from a supplier unrelated to the manufacturer that has suspended distribution.Oyster Point has tested samples of varenicline tartrate API intermediate, multiple lots of varenicline tartrate drug substance used in OC-01 (varenicline) nasal spray finished product, and multiple lots of OC-01 (varenicline) nasal spray finished product with no evidence of nitrosamine levels being above the lower limit of detection from the assay used for measuring presence, it said.The Prescription Drug User Fee Act ((PDUFA)) target action date for OC-01

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Oyster Point says impurities not a concern in its varenicline nasal spray