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Re: richme post# 160872

Saturday, 08/01/2015 12:20:57 PM

Saturday, August 01, 2015 12:20:57 PM

Post# of 409152
We've launched, what - 8 products... since you were personally concerned that we could launch ANY. Seems like we are REALLY moving in the right direction. Here's a list for you in case you forgot...

Hydromorphone Hydrochloride 8 mg Tablets
Naltrexone Hydrochloride 50 mg Tablets Revia®
Phentermine HCl 37.5 mg Tablets Adipex-P®
Phentermine HCI 15 mg and 30 mg Capsules
Phendimetrazine Tartrate 35 mg Tablets
Isradipine 2.5 mg and 5 mg Capsules
Methadone Hydrochloride 10 mg Tablets
And of course the branded product Lodrane D®

BUT WAIT... THERE's MORE! Here's what's in the queue ready for release... again, in case you forgot...
Hydroxyzine HCI 10 mg, 25 mg, 50 mg Tablets
Dantrolene Sodium 25 mg, 50 mg and 100 mg Capsules
Loxapine 5 mg, 10 mg, 25 mg, 50 mg Capsules
Additional Approved ANDA's...

This doesn't even include all of the work done for the ART products... for example...

HAL Study: Completed / POSITIVE
Label dosing study: A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects - Completed / POSITIVE

And the big one...

Phase III - A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain - FINAL REPORT DUE AUGUST.... this month!

So yeah - a LOT has happened since many thought we couldn't get ONE product out the door. The company has more than DOUBLED in size with employees - bringing in top rate talent. The manufacturing facility has added 10's of 1,000's of cubic feet of space - oh, and installed BRAND NEW EQUIPMENT capable of cranking out multiple product lines at high capacity.

Looking forward to the NDA SUBMISSION THIS YEAR!!!!



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