Biopharmaceutical company Kindred Biosciences Inc (NASDAQ:KIN) said on Tuesday that the Food and Drug Administration (FDA) for the Chemistry, Manufacturing and Controls technical section has no additional questions or requests regarding the submission of Zimeta IV for the control of fever in horses.
The company added that the US FDA stated that Zimeta IV's approval is pending the pre-approval inspection, or PAI, at the contract manufacturer of Zimeta IV scheduled for July 2018 and an acceptable resolution by the contract manufacturer of the active pharmaceutical ingredient (API) dipyrone of findings identified during an inspection conducted in April. The findings at the API manufacturer are minor and addressable.
In addition, the company continues to anticipate approval of its first product, Mirataz (mirtazapine transdermal ointment), for the management of weight loss in cats on or before the 6 May 2018 action date.
According to the company, the US FDA does not have any additional questions or requests with respect to Mirataz, final label negotiations have been completed and all of the required inspections have been completed successfully at the contract manufacturers.
On 8 May 2018, the company will provide further programme and corporate updates during its Q1 2018 financial call at 16:30 Eastern Time / 13:30 Pacific Time. The call will be webcast live at https://edge.media-server.com/m6/p/nhw6xeop.
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