Woodbrook Group Holdings Inc (WDBG)

[BRICK_TOP]

(Brick loves patents and FDA approvals).

From Grolden’s DD:

DEPARTMENT OF HEALTH AND HUMAN SERVICES NDA 206679/S-002 TCG Fluent Pharma Investors LP Attention: David Ambrose
16255 Aviation Loop Brooksville, FL 34604 Dear Mr. Ambrose: Please refer to your Supplemental New Drug Application (sNDA) dated April 4, 2017, received April 6, 2017, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for FloLipid (simvastatin) oral suspension, 20 mg/5 mL and 40 mg/5 mL. This Prior Approval supplemental new drug application proposes changes to container labels, carton labeling, and Prescribing Information (PI) to include the proprietary name, FloLipid, which was found acceptable by FDA’s Division of Medication Error Prevention and Analysis on July 3, 2017. APPROVAL & LABELING We have completed our review of this supplemental application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206679Orig1s002ltr.pdf