Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

Lyrica CR (extended release) APPROVED 10/11/2017. Pfizer's NDA 209501 for extended release Lyrica got final approval. The doses are 82.5MG, 165MG, and 330MG.

Pfizer got their Lyrica CR approved before the patent for immediate release Lyrica expires December 30, 2018. Looks like Pfizer completed their Phase 3 studies a few years ago. They filed the NDA on December 15, 2016 last year.

Lyrica CR approval letter:
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209501Orig1s000ltr.pdf

Lyrica CR labeling:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf

POST-MARKETING AGREEMENT
For release, dissolution data (at 1, 4, 9 and 24 hours) on all commercial scale batches of drug product manufactured.

For stability, dissolution data (at 1, 4, 9 and 24 hours) on the first three commercial scale batches of drug product manufactured

Proposed dissolution acceptance criteria at each time point.