Strides Receives USFDA Approval For Levetiracetam Oral Solution

Strides Receives USFDA Approval For Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures.

FPJ Web DeskUpdated: Tuesday, November 21, 2023, 11:17 AM IST
article-image
Strides Receives USFDA Approval For Levetiracetam Oral Solution |

Strides Pharma Science Limited (Strides) on Tuesday announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the United States Food & Drug Administration (USFDA), the company announced through an exchange filing.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures.

The Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

Strides Pharma Science Limited shares

The shares of Strides Pharma Science Limited on Tuesday at 11:04 am IST were at Rs 507.65, up by 3.49 percent.

RECENT STORIES

Tata Group-Owned Indian Hotels Net Profit Jumps 26.56% To ₹329 Crore In Q1 FY26, Revenue Rises To...

Tata Group-Owned Indian Hotels Net Profit Jumps 26.56% To ₹329 Crore In Q1 FY26, Revenue Rises To...

Hexaware Acquires 100% Stake In SMC Squared For ₹1,029 Crore To Boost Global Capability Centre...

Hexaware Acquires 100% Stake In SMC Squared For ₹1,029 Crore To Boost Global Capability Centre...

Waaree Renewable's Q1 Net Profit Rises 207% YoY To ₹86 Crore Despite Sequential Dip; Revenue Jumps...

Waaree Renewable's Q1 Net Profit Rises 207% YoY To ₹86 Crore Despite Sequential Dip; Revenue Jumps...

Gold Slips ₹200 To ₹98,670/10g, Silver Tumbles ₹500 To ₹1,10,500/Kg

Gold Slips ₹200 To ₹98,670/10g, Silver Tumbles ₹500 To ₹1,10,500/Kg

Axis Bank Q1 FY26 Net Profit Falls 4% To ₹5,806 Crore Amid Rise In Bad Loans

Axis Bank Q1 FY26 Net Profit Falls 4% To ₹5,806 Crore Amid Rise In Bad Loans