Generic Asacol HD Still Waiting on FDA Approval

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Asacol HD (mesalamine delayed-released) is an anti-inflammatory indicated for the treatment of moderately active ulcerative colitis in adults. After regular Asacol was discontinued in 2013, you may have switched to Asacol HD or Delzicol—and been left waiting for a generic alternative.

A couple of years later, a generic for Asacol HD was finally set for launch on November 15, 2015. However, the launch didn’t happen, and there is now no current estimate for the new launch date.

Delays at a manufacturing facility in Moraiya, India are thought to be the cause. There have even been some rumors that the facility may not be cleared to make the generic before the end of the fiscal year. The delayed launch has caused generic manufacturer Cadila Health’s stock to plummet by as much as 4%.

Here’s what you need to know if you’re waiting for a generic mesalamine tablet.

How is Asacol HD used?

The recommended dose of Asacol HD is two 800 mg tablets taken three times daily.

When was generic Asacol HD (mesalamine delayed-release) supposed to be launched?

The Asacol HD generic was scheduled for launch on November 15, 2015.

When will generic Asacol HD be available now?

At this time there is no information on when the generic for Asacol HD will be available.

I take Asacol HD and I’ve been waiting on the generic. Now what?

If you take Asacol HD and were anticipating the launch of the generic product this month, unfortunately there aren’t many options but to continue waiting for the FDA approval.

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