Aveva Secures First FDA Nod for Lidocaine 1.8% Patch Launch

Aveva Drug Delivery Systems Celebrates FDA Approval

Aveva Drug Delivery Systems (a DifGen company) is excited to announce a significant achievement as the U.S. Food and Drug Administration (FDA) has granted approval for its generic Lidocaine 1.8% Patch. This groundbreaking patch serves as an effective non-opioid topical treatment for patients suffering from post-herpetic neuralgia (PHN) and localized nerve pain, representing a step forward in affordable healthcare solutions.

The Importance of the Lidocaine 1.8% Patch

The generic Lidocaine 1.8% Patch is a non-hydrogel topical product designed to deliver a concentrated dose of lidocaine directly to the painful area. This method of delivery allows for targeted relief at the source of pain while minimizing the side effects commonly associated with oral medications. By providing a more accessible generic version of the branded ZTlido®, DifGen is committed to enhancing patient access to essential pain management therapies.

Benefits of the Lidocaine 1.8% Patch

Patients and healthcare professionals will find several key benefits in the use of the generic Lidocaine Patch:

1. Targeted Pain Relief

By applying the patch directly to the area in need, patients experience localized relief that is both effective and swift. This targeted approach improves the overall effectiveness of the treatment, enhancing patient comfort.

2. Non-Invasive Treatment Option

Unlike traditional medications that require oral ingestion, this patch provides a non-invasive option, significantly reducing the risk of adverse reactions typically linked with systemic medications. Patients can have peace of mind as they manage their symptoms.

3. User-Friendly Design

Designed for simplicity, the patch is easy to apply and can deliver continuous relief for up to 12 hours. This allows patients to lead their daily lives with minimal interruption, granting them the freedom to engage in activities they love without the constant distraction of pain.

Regulatory Approval Journey

Aveva proudly positions itself as the first applicant to secure an FDA approval for the generic Lidocaine 1.8% Patch. The approval communication highlighted that Aveva submitted a complete Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, potentially qualifying the company for 180 days of exclusivity in the generic market. However, the FDA's official determination on exclusivity remains pending.

Leadership Insights

Ramandeep Singh Jaj, Founder and co-CEO of DifGen, expressed enthusiasm about this FDA approval, stating, "This marks a vital milestone in our journey towards delivering high-quality pain management solutions to patients." The co-CEO, Dr. Santhanakrishnan Srinivasan, emphasized the innovative technology adopted in the development of the Lidocaine Patch, noting their commitment to exceeding the stringent safety and efficacy standards required in f the market.

DifGen's Commitment to Quality Care

DifGen is renowned for its development of complex generic and specialty pharmaceutical products that promise increased access to high-quality medications. Their focus on innovation and best practices allows the company to lead in transforming healthcare for communities. The talented team at DifGen tackles product development challenges head-on, ensuring effective solutions across various therapeutic categories.

About Aveva Drug Delivery Systems

Aveva Drug Delivery Systems operates as a fully integrated developer and manufacturer of specialized products, including transdermal delivery systems and oral dissolvable films. Their facilities are equipped to manufacture, package, and market over-the-counter (OTC) and prescription (Rx) products, while adhering to the regulatory requirements for controlled substances. Avenue's extensive facility network highlights their capability to meet the growing demand for innovative drug delivery solutions.

Frequently Asked Questions

What is the Lidocaine 1.8% Patch used for?

The Lidocaine 1.8% Patch is primarily used for the treatment of localized nerve pain, especially post-herpetic neuralgia.

How does the Lidocaine Patch work?

The patch works by delivering lidocaine directly at the pain site, providing targeted relief without the systemic effects of oral medications.

How long can the patch be worn?

Patients can wear the patch for up to 12 hours, providing consistent pain management throughout the day.

What does FDA approval mean for Aveva?

The FDA approval is a significant milestone, allowing Aveva to offer a cost-effective solution for nerve pain management and may provide a period of exclusivity in the market.

Where is Aveva Drug Delivery Systems located?

Aveva Drug Delivery Systems operates from multiple facilities located in Florida, with a focus on quality manufacturing and regulatory compliance.

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