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Current Development Targets
Product |
Application |
Potential Advantages |
Comments |
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12 hr Ibuprofen |
OTC Analgesic |
- 1st controlled release OTC ibuprofen
- 1 tablet vs. 3 every 12 hrs.
- Lower cost
- Patent protected |
Successful Pivotal Phase III completed
Actual Use Study required prior to FDA submission
NDA 505(B)2 planned 2010 |
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12 hr Pseudoephedrine |
OTC Decongestant |
- 1/3rd size of current OTC products
- Lower cost
- Patent protected |
ANDA submitted August 2008
Complete Response Letter received January 2009 with minor (CMC) deficiencies noted
Currently under review
Anticipate approval and commercialization in 2010 |
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Clinical Experience
Following are additional targets with completed clinical work pending additional financing or partnerships.
Product |
Application |
Comments |
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IR Raloxifene |
Rx Osteoporosis |
Two pilot pharmacokinetic trials completed |
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ER Ondansetron |
Rx Anti-Nausea |
Two pilot pharmacokinetic trials completed |
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ER Phenylephrine |
OTC Decongestant |
Initial pilot pharmacokinetic trial completed |
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ER Niacin |
Cardiovascular |
In-vivo performance comparable to Niaspan® |
Niaspan® is a trademark of Abbott Laboratories.
Formulation Experience
Product |
Application |
Features |
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Guaifenesin |
Expectorant |
Sustained release tablet formulation |
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Ibuprofen/Pseudoephedrine |
Cough-Cold |
Sustained release analgesic and decongestant combination |
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Fenofibrate (Tricor®) |
Hypercholesterolemia, Hypertriglyceridemia |
Novel immediate release tablet
Novel solid dispersion formulation |
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Gabapentin (Lyrica®) |
Pain Management |
Novel 12 hour controlled release tablets |
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Tramadol (Ultram®) |
Pain Management |
Novel 12 and 24 hour controlled release tablets |
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Propranolol (Inderal LA®) |
Beta-Blocker |
Comparable to reference listed drug |
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Metoprolol (Toprol XL®) |
Beta-Blocker |
Comparable to reference listed drug |
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Diltiazem HCl (Dilacor®) |
Ca channel Blocker |
Comparable to reference listed drug |
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Nifedipine (Procardia®) |
Ca channel Blocker |
Comparable to reference listed drug |
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Verapamil (Covera-HS®) |
Ca channel Blocker |
Comparable to reference listed drug |
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Rivastigmine (Exelon®) |
Alzheimer’s Disease |
Novel 24 hour controlled release tablets |
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Risperidone (Risperdal®) |
Schizophrenia/Bi-Polar |
Novel 24 hour controlled release tablets |
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Glipizide (Glucotrol® XL) |
Diabetes |
Comparable to reference listed drug |
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Metformin (Glucophage® XR) |
Diabetes |
Comparable to reference listed drug |
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Dimenhydrinate (Dramamine®) |
Motion Sickness |
Novel 24 hour controlled release tablets |
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Theophylline (Theo-Dur®) |
Asthma, Bronchodilator |
Novel 12 hour controlled release tablets |
Tricor® is a trademark of Abbott Laboratories; Lyrica®, Procardia®, Glucotrol®, Dramamine® and Covera-HS® are trademarks of Pfizer; Ultram® and Risperdal® are trademarks of J&J; Inderal LA® is a trademark of Wyeth; Toprol® is a trademark of AstraZeneca; Dilacor® is a trademark of Watson; Exelon® is a trademark of Novartis; Glucophage® is a trademark of Bristol-Myers.
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