Strides gets USFDA nod for anti-allergic drug

NEW DELHI, Jan 16: Strides Pharma Science on Thursday said it has received approval from the US health regulator for Loratadine Softgel Capsules, a medication typically used to treat allergies.
In a filing to BSE Strides said its “step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has received approval for Loratadine Softgel Capsules, 10 mg (OTC) from the United States Food & Drug Administration (USFDA).”
The product is a generic version of Claritin Liqui-Gels Capsules, 10 mg, of Bayer HealthCare LLC, the filing said.
Loratadine Softgel Capsule is used to relieve symptoms of seasonal allergy (seasonal allergic rhinitis) and other upper respiratory tract allergies.
The company said, it is focusing on building a private label business in the US by leveraging its portfolio of products across softgels, tablets, capsules and other proprietary formats.
Loratadine Softgel Capsules, 10 mg (OTC) is part of Strides niche and small volume product portfolio with limited competition in the US private label market, the filing said.
According to IRi data, the US market for Loratadine Softgel Capsules, 10 mg (OTC) is around USD 50 million with only one other generic approval.
The product will be manufactured at the company’s oral dosage facility at Bengaluru.
The company has 102 cumulative ANDA filings with USFDA of which 68 abbreviated new drug applications (ANDAs) have been approved and 34 are pending approval.