Zydus’ Methylene Blue Injection Gains USFDA Nod

The approval was granted to Methylene Blue Injection in 10mg/2ml and 50mg/5ml formulations, allowing it to market in the US. The novel injection is an oxidation-reduction agent indicated for treating pediatric and adult patients with acquired methemoglobinemia.

Zydus, an Indian pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for its Methylene Blue injection.

The approval was granted to Methylene Blue Injection in 10mg/2ml and 50mg/5ml formulations, allowing it to market in the US. The novel injection is an oxidation-reduction agent indicated for treating pediatric and adult patients with acquired methemoglobinemia.

Currently, the annual sale of Methylene Blue Injection, 10mg/2ml, and 50mg/5ml in the United States is estimated to be around USD 73.4 million. This move aligns with the company's aim to supply affordable complex generic medications to patients in need and strengthen the US supply chain of care.

Expressing his thoughts, Dr Sharvil Patel, managing director of Zydus Lifesciences Limited said, ‘’Methylene blue is a cationic thiazine dye requiring specialised capabilities and expertise to develop and manufacture the product. The efforts of our team who have worked on the development, filing and manufacturing of Methylene Blue Injection reflects our ongoing commitment to bringing complex generic products accessible to patients who need them the most."

Zydus Lifesciences, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company founded in 1952 by Ramanbhai Patel. The company is thoroughly engaged in producing formulations for active pharmaceutical ingredients, animal healthcare products, and wellness products.

Globally, the group is well-represented in the highly visible markets of Latin America and South Africa as well as the regulated markets of the US and Europe (France and Spain). It is also well-established in 25 other developing markets throughout the world.

Last month, Lupin joined hands with Zydus to co-market saroglitazar mg for chronic liver diseases in India. The primary objective of this collaboration is to introduce a potentially effective treatment for chronic liver diseases in the country.

Under this alliance, Lupin obtained semi-exclusive rights to co-market the product in India under the brand name LINVAS®, while Zydus continues marketing the drug under the brand names Lipaglyn® and Bilypsa®.

Meanwhile, Zydus Lifesciences collaborated with Guardant Health, a US-based precision oncology leader, to introduce advanced biopsy tests in India and Nepal, addressing the need for improved cancer treatment options.