USFDA

Aurobindo Pharma has received final approval from the US Food and Drug Administration to manufacture and market a generic version of glycerol phenylbutyrate oral liquid, a treatment for urea cycle disorders. The product, with a strength of 1.1 gram per ml, is therapeutically equivalent to the branded drug Ravicti. With an estimated market size of USD 50.2 million (approximately Rs 420 crore), the approval marks a strategic addition to Aurobindo’s U.S. portfolio, reinforcing its position in niche and specialty therapeutic segments.

Regulatory Milestone Enhances Product Pipeline

Alembic Pharmaceuticals has achieved a significant regulatory milestone with final approval from the US Food and Drug Administration (USFDA) for its generic dapagliflozin tablets, a widely used treatment for Type 2 diabetes. The approval enables the company to market therapeutically equivalent versions of AstraZeneca’s Farxiga in the US, expanding its footprint in the high-value anti-diabetic segment. This development underscores Alembic’s strategic focus on complex generics and regulated markets.

Lupin Ltd has received tentative approval from the US Food and Drug Administration for its generic version of Pitolisant tablets, used to treat excessive daytime sleepiness. The approval, granted under the abbreviated new drug application (ANDA) pathway, covers strengths of 4.45 mg and 17.8 mg. The product will be manufactured at Lupin’s Nagpur facility, reinforcing its global manufacturing footprint. This development highlights Lupin’s continued focus on expanding its central nervous system (CNS) portfolio while strengthening its presence in the highly regulated US generics market.