Glenmark Receives Complete Response Letter from FDA for Mfg

By Emily Forster -

June 27, 2019

Glenmark Pharmaceuticals, a generics pharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding manufacturing issues relating to its new drug application (NDA) for Ryaltris (olopatadine hydrochloride and mometasone furoate), a nasal spray.

The FDA sends an applicant a CRL if the agency determines that it will not approve the application in its present form for one or more of the reasons given in the application for FDA approval to market the new drug.

The CRL cites deficiencies in the drug master file pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities. The CRL does not specify any deficiencies with the clinical data supporting the NDA for Ryaltris.

Glenmark says it should be able to resolve these issues within the next six to nine months and will continue to pursue regulatory approval for Ryaltris and will work closely with the FDA to determine the appropriate next steps.

Source: Glenmark