Granules Pharmaceuticals Secures FDA Approval for Lisdexamfetamine Dimesylate Chewable Tablets
核心洞察
Granules Pharmaceuticals (搜索) has received FDA approval for its ANDA for Lisdexamfetamine Dimesylate Chewable Tablets, used to treat ADHD and BED.
The approved drug, bioequivalent to Takeda's Vyvanse, comes in strengths of 10 mg to 60 mg, addressing critical shortages in the U.S. market.
This approval marks Granules India's 68th ANDA approval, including 30 secured through its subsidiary, reinforcing its commitment to affordable medications.
Granules Pharmaceuticals (搜索) (GPI), a subsidiary of Granules India, has obtained U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. This approval addresses a critical need, as the medication is indicated for treating Attention Deficit Hyperactivity Disorder (搜索) (ADHD) in adults and children aged six years and older, as well as Moderate to Severe Binge Eating Disorder (搜索) (BED) in adults.
The approved Lisdexamfetamine Dimesylate Chewable Tablets will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. The product is bioequivalent to Vyvanse Chewable Tablets, manufactured by Takeda Pharmaceuticals (搜索) USA. This bioequivalence ensures that patients receive the same therapeutic benefits as the branded medication.
Addressing Drug Shortages
Notably, Lisdexamfetamine Dimesylate Chewable Tablets are currently listed on the FDA Drug Shortages List, highlighting the urgency and importance of this approval in alleviating supply issues within the U.S. healthcare system. The availability of a generic alternative is expected to improve patient access to this essential medication.
Company Statement
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules, commented on the approval, stating, "This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market."
Expanding Product Portfolio
This latest approval brings Granules India’s total ANDA approvals to 68, including 30 approvals secured through GPI, further solidifying the company's position in the pharmaceutical market.