|

|
Programs Under Development |
Branded Products (a) |
Therapeutic
Category |
NDA / ANDA |
Development Stage (b) |
Partnered |
|
Oxycodone CR Once a day |
NA |
Pain |
NDA |
Phase III pending |
No |
|
Abuse Resistance Product for use with
Oxycodone or other opioids |
N/A |
Pain |
NDA |
Phase II |
No |
|
Diltiazem Once a day |
Cardizem CD® |
Cardiovascular |
ANDA |
Pilot BE study complete |
No |
|
Lodrane Once a Day |
N/A |
Allergy |
NDA |
Launched |
Yes ECR Pharmaceuticals |
|
Lodrane 24D
Once a day |
N/A |
Allergy |
NDA |
Launched |
Yes ECR Pharmaceuticals |
|
Undisclosed Twice a Day |
Undisclosed |
Infection |
ANDA
|
Pilot BE study complete |
Yes |
(a) The name of our competitor’s branded product.
(b) Preclinical testing refers to studies done before initiation
of any human studies. Pilot Phase I studies for the NDA products are generally
preliminary studies done in healthy human subjects to assess the
tolerance/safety and pharmacokinetics (PK) of the product. Additional larger
studies in humans will be required prior to submission of this product to the
FDA for review. Pilot bioequivalence (BE) studies are initial studies done in
humans for generic products and are used to assess the likelihood of achieving
bioequivalence for generic products. Larger pivotal bioquivalence studies will
be required prior to submission of the product for FDA for review.
|