Strides gets USFDA nod for anti-allergic drug

Strides Pharma Science said that it has received approval from the US health regulator for Loratadine Softgel Capsules, which is typically used to treat allergies. According to the company's 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)."

Loratadine Softgel Capsules is a generic version of Claritin Liqui-Gels Capsules, 10 mg, of Bayer HealthCare LLC, the filing said.

The product helps in treatment of seasonal allergy (seasonal allergic rhinitis) and other upper respiratory tract allergies.

Currently, the company is focusing on developing its private label business in the US by expanding its portfolio of products across softgels, tablets, capsules and other proprietary formats.

According to the filing, 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.

According to IRi data, the US market for Loratadine Softgel Capsules, 10 mg (OTC) is around US$ 50 million with only one other generic approval.
The company's oral dosage facility at Bengaluru will be responsible for manufacturing the product.

So far, the company has 102 cumulative ANDA filings with USFDA out of which approved are 68 abbreviated new drug applications (ANDAs) and rest 34 are pending approval.

The shares of Strides Pharma Science Ltd were trading at Rs 387.05 (US$ 5.53) a piece on BSE, down 0.65 per cent.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.