Introduction:
Granules India, a distinguished participant in the pharmaceutical industry, has introduced a extensive milestone as its totally-owned subsidiary, Granules Pharmaceuticals Inc. (GPI), acquired approval from america Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable drugs. This approval marks the advent of a prevalent model of Vyvanse, a widely prescribed drug for attention deficit hyperactivity disorder (ADHD) and binge consuming ailment (BED).
Highlights:
Product Overview: The approved Lisdexamfetamine Dimesylate chewable tablets come in multiple strengths, ranging from 10 mg to 60 mg. This formulation is bioequivalent (AB Rating) to the branded Vyvanse chewable tablets by Takeda Pharmaceuticals, providing patients with a more affordable alternative for ADHD and BED treatment.
Indications and Market Impact: The drug is indicated for the treatment of ADHD in both adults and children aged six and older, and for moderate to severe binge eating disorder in adults. It is noteworthy that the approved drug is listed on the FDA’s drug shortages list, underscoring its critical role in alleviating existing supply gaps in the U.S. healthcare system.
Granules India Secures USFDA Approval for Generic Lisdexamfetamine, Expanding Access to ADHD and BED Treatment
Strategic Importance: Granules India’s chairman and managing director, Dr. Krishna Prasad Chigurupati, highlighted the company’s commitment to meeting patient needs by delivering high-quality, affordable medications. The approval not only reflects Granules’ ability to provide essential medicines but also its strategic contribution to resolving drug shortages in the U.S.
Market Outlook: With this approval, Granules India now holds 68 ANDA approvals, including 30 from its U.S.-based subsidiary GPI. This strengthens Granules’ position in the U.S. generic pharmaceutical market, a key growth area for the company.
Financial Performance:
Despite this significant regulatory win, Granules India faced a dip in financial performance for Q2 FY25. The company reported a 4.79% decline in net profit to Rs 97.23 crore, coupled with a notable 18.74% drop in revenue to Rs 966.62 crore compared to Q2 FY24.
This decline in revenue reflects broader market challenges, but the recent USFDA approval is expected to bolster future growth prospects.
Conclusion:
Granules India’s successful USFDA approval for Lisdexamfetamine Dimesylate chewable tablets underscores its growing footprint in the global pharmaceutical market. As the company continues to address critical drug shortages and expand its portfolio, this approval enhances its reputation as a key supplier of affordable, high-quality generic medications, with a particular focus on improving access to ADHD and BED treatments.
This approval also positions Granules India well to navigate future challenges in the pharmaceutical landscape and unlock new growth avenues in the U.S. market.
FAQ:
1. What is Lisdexamfetamine Dimesylate chewable tablet?
Lisdexamfetamine Dimesylate chewable tablets are a generic form of Vyvanse, a medication used to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). The chewable tablets come in multiple strengths, including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
2. What is the significance of the USFDA approval for this drug?
The USFDA approval marks a major milestone for Granules India, as it validates the safety, effectiveness, and bioequivalence of their Lisdexamfetamine Dimesylate chewable tablets to the branded Vyvanse tablets. This approval not only offers a more affordable alternative for patients but also addresses critical drug shortages in the U.S. market.
3. What conditions does Lisdexamfetamine Dimesylate treat?
The medication is primarily indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six and older.
- Moderate to severe Binge Eating Disorder (BED) in adults.
4. How is Granules India’s version of Lisdexamfetamine different from Vyvanse?
Granules India’s Lisdexamfetamine Dimesylate is a generic version of Vyvanse, meaning it contains the same active ingredient and works the same way in the body. The key difference is that the generic version is typically offered at a more affordable price, making it more accessible for patients.
5. What does it mean that Granules’ product is “bioequivalent” to Vyvanse?
Being “bioequivalent” means that Granules’ Lisdexamfetamine Dimesylate chewable tablets have the same strength, dosage form, and absorption rate in the body as the branded Vyvanse. This ensures that both drugs provide the same therapeutic effect for patients.
6. Why is this approval particularly important for the U.S. market?
This approval is significant because Lisdexamfetamine Dimesylate is listed on the FDA’s drug shortages list, meaning there is a critical demand for this medication in the U.S. By offering a generic alternative, Granules India helps address the shortage, improving access for patients who rely on this medication for ADHD and BED treatment.
7. What is the impact of this approval on Granules India’s business?
This approval strengthens Granules India’s position in the U.S. market, adding to its growing portfolio of ANDA (Abbreviated New Drug Application) approvals. It also provides a potential revenue boost as the company addresses unmet needs in the pharmaceutical market, especially in light of the ongoing drug shortages.
8. How many ANDA approvals does Granules India now have?
Following this approval, Granules India now holds a total of 68 ANDA approvals, with 30 of them granted to its wholly-owned subsidiary, Granules Pharmaceuticals Inc. (GPI), based in the U.S.
9. What was Granules India’s recent financial performance?
For Q2 FY25, Granules India reported a 4.79% decline in net profit, totaling Rs 97.23 crore. The company also saw a decrease in revenue by 18.74%, totaling Rs 966.62 crore, compared to the same quarter in the previous fiscal year. However, the approval of this ADHD drug is expected to support future growth.
10. What does Granules India aim to achieve with this approval?
Granules India aims to provide high-quality, affordable medications to patients while also addressing critical healthcare challenges like drug shortages. The approval reflects the company’s commitment to improving global access to essential medicines, particularly in the U.S. market.
11. How does this approval affect the treatment options for ADHD and BED?
This approval provides patients with an additional, more affordable treatment option for ADHD and BED. By offering a generic version of Vyvanse, Granules India is contributing to improving access to these essential medications, which may otherwise be expensive for some patients.
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