Indian drugmaker Strides received the FDA’s go-ahead for its generic over-the-counter 10mg softgel capsules of loratadine, an antihistamine for treating hives and allergy symptoms.
The product is a copycat of Bayer’s Claritin Liqui-Gel capsules, which come in the same strength. Only one other generic approval has been given for the drug, the company said.
Strides has made 102 ANDA filings with the FDA and has seen 68 of them approved so far. The rest are still pending.