Granules India Limited, a leading Indian pharmaceutical company, announced that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lisdexamfetamine dimesylate chewable tablets. The drug is approved in multiple strengths, including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
Bioequivalence to Vyvanse
The approved generic product has been determined to be bioequivalent (AB Rating) to Vyvanse chewable tablets, marketed by Takeda Pharmaceuticals USA Inc. This drug is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in both adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults.
Significant Achievement for Granules India
Granules India now holds a total of 68 ANDA approvals, with 30 of these from its subsidiary, GPI. The FDA granted approval for lisdexamfetamine dimesylate chewable tablets in the first review cycle, showcasing Granules’ focus on regulatory excellence and efficient product delivery.
Addressing Critical Drug Shortages
Lisdexamfetamine dimesylate chewable tablets are currently listed on the FDA Drug Shortages List, underscoring their importance in patient care. This approval plays a crucial role in alleviating shortages and ensuring the availability of essential medications in the US market.
Commitment to Affordable Medications
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India, expressed his satisfaction with the approval. He stated, “This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI strengthens its role in resolving critical drug shortages in the US healthcare market.”
Conclusion
Granules India’s latest FDA approval reinforces its dedication to delivering affordable and high-quality medicines, ensuring better healthcare access, and addressing critical drug shortages in the US.