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Advanced Patented Generics Services
FromLaxxon Medical
Through our proprietary SPID®-Technology, we can repurpose, reposition, and relaunch generic APIs with patent protection while also addressing common issues with generic drugs such as patient compliance, dosage, and side effects. Our Advanced Patented Generics are going to be registered in the US under the FDA Section 505(b)(2), a fast-tracked regulatory approval process. In the EU, our Advanced Patented Generics will be registered as the Hybrid applications under Article 10(3) of Directive 2001/83/EC.
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The ideal 505(b)(2) candidates are:
- Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration
- Drugs with new active ingredients (in some cases)
- Drugs with new indications
- New combination product
- Prodrugs of an existing drug