On the 26th, Andros Pharmaceuticals announced that its independently developed topical anesthetic cream, “LTC Cream”, has received marketing approval from Taiwan’s Food and Drug Administration (TFDA). The product, indicated for pain relief on the skin surface, is the first approved generic drug in Taiwan under the TFDA’s new “Guideline for Verifying Therapeutic Equivalence of Topical Preparations”, issued last year. This milestone signifies a significant step forward for the company and the industry.
Andros Pharmaceuticals noted that the U.S. FDA introduced specific regulatory requirements for topical formulations in 2019, prompting other countries to follow suit. In response, Taiwan’s TFDA released updated guidelines to align with international standards. Leveraging its expertise in developing innovative topical formulations and its PICS/GMP-certified manufacturing facilities, Andros quickly adapted to these new regulations, securing Taiwan’s first generic drug approval for a topical product. This demonstrates the company’s technical capabilities and commitment to meeting international standards.
LTC Cream combines lidocaine (7%) and tetracaine (7%), two local anesthetics. It is currently the most concentrated combination product approved by both the U.S. FDA and the EU EMA. The cream is designed for use in superficial dermatological procedures requiring local anesthesia, such as dermal filler injections, pulsed dye laser treatments, facial resurfacing, and tattoo removal. The product’s unique feature is its cream-based formulation, which forms a soft film upon exposure to air. The film allows the controlled release of lidocaine and tetracaine into the skin, achieving rapid local anesthetic effects.
Current methods for pre-procedural anesthesia in superficial dermatological or cosmetic surgeries often involve injectable anesthetics, which can cause significant discomfort for patients. Invasive injections may alter the skin’s surface contour and leave puncture marks that could lead to scarring. Therefore, transdermal administration is increasingly preferred for local anesthesia.
The most commonly used topical anesthetics on the market include EMLA cream and Pliaglis cream. EMLA contains 2.5% prilocaine and 2.5% lidocaine but has a slower onset of action and requires a protective covering during the waiting period, which is inconvenient.
Pliaglis cream, which contains 7% tetracaine and 7% lidocaine, forms a soft film when exposed to air. This film allows the anesthetics to penetrate the skin and can be easily peeled off after use. According to published studies, applying Pliaglis 30 minutes before surgery provides twice the anesthetic effect of EMLA, with an onset time that is twice as fast. It is currently the fastest-acting, most potent, and longest-lasting topical anesthetic on the market, with annual global sales exceeding $200 million.
Andros’ LTC Cream contains the same active ingredients as Pliaglis. However, the original product is not sold domestically, and its Taiwan import license will expire in January next year. This means LTC Cream is not only the first approved generic but also the only high-concentration, fast-acting, and high-quality topical anesthetic available locally. Its launch is expected to revolutionize the domestic surgery and medical aesthetics market. The company also plans to actively pursue licensing opportunities and expand into international markets.
According to The Business Research Company, the global market for local anesthetics is projected to grow from $4.54 billion in 2024 to $5.65 billion by 2028, with a compound annual growth rate (CAGR) of 5.6%.
Resource: 竟天「舒膚麻乳膏」搶下首發學名藥證 開局部麻藥市場新商機
