China Securities Intelligent Financial Information Humanwell Pharmaceutical (Rights Protection)(600079) announced on the evening of May 16 that recently, the company's wholly-owned subsidiary, EpicPharma,LLC, received approval number for acetazolamide tablets and difluprednoxil ophthalmic lotion from the US Food and Drug Administration (FDA).

According to the announcement, acetazolamide tablets are carbonic anhydrase inhibitors and are used to treat glaucoma, epilepsy, acute alpine sickness, periodic paralysis, idiopathic intracranial hypertension (elevated brain pressure with unknown cause), heart failure and drugs that alkalize urine. Epic Pharma submitted an ANDA application for acetazolamide tablets in June 2023, with a cumulative R & D investment of approximately US$1.2 million. According to IQVIA data, the total sales of this drug in the U.S. market in 2023 will be approximately US$13 million. Major manufacturers include Strides, Lifestar, etc.

Difluprednoxil ophthalmic lotion is used to treat local inflammation and pain after eye surgery. In May 2023, Epic Pharma acquired the difluprednoxil ophthalmic lotion project under FDA review. It was subsequently approved through supplementary research and communication with the FDA. The cumulative acquisition and subsequent research and development investment is approximately US$800,000. According to IQVIA data, the total sales of this drug in the U.S. market in 2023 will be approximately US$29 million. Major manufacturers include Sandoz, Amenal, and Dr.nftontron.Reddys et al.

Humanford Pharmaceutical said that the approval number of acetazolamide tablets and difluprednoxil ophthalmic emulsion by the U.S. FDA marks that Epic Pharma is qualified to sell the above products in the U.S. market, which will help the company expand the U.S. generic drug market. With a positive impact, Epic Pharma will actively promote the preparations for the launch of the above products in the U.S. market in the future.

(Article sourcenftontron: China Securities Journal·China Securities Network)