Hyderabad: Dr. Reddy’s Laboratories Ltd on Monday said it has got tentative approval from the US Food and Drug Administration (USFDA) for its 40 mg Zenavod antibiotic capsules to treat rosacea, a skin condition.
Generically known as doxycycline, Zenavod is used to treat rosacea that causes redness in the face and often produces small red bumps. It commonly affects middle-aged women who have fair skin.
In a statement, Dr. Reddy’s said its US subsidiary Promius Pharma will be responsible for commercialising Zenavod in the US.
“This development confirms our ability and commitment to develop differentiated dermatology products, leveraging the in-house capabilities of Promius Pharma LLC and Dr. Reddy’s," stated G.V. Prasad, chief executive officer and co-chairman, Dr. Reddy’s.
“We are pleased to receive a tentative FDA approval of Zenavod and will be working with external parties and the FDA to gain a full approval," Prasad said.
Dr. Reddy’s said the approval of the new drug application (NDA) is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act.
Galderma Laboratories LP, Nestle Skin Health SA and TCB Royalty Sub LLC have sued Dr. Reddy’s for infringement of certain patents related to doxycycline 40 mg capsules, which it markets under brand name ORACEA in US for treatment of acne, in the United States District Court for the district of Delaware.
“The tentative approval for Zenavod is another step toward providing an additional option for people with rosacea in the US, who need oral treatment," said Raghav Chari, executive vice president of proprietary products at Dr. Reddy’s and president of Promius Pharma.
Along with biosimilars, Dr. Reddy’s is betting big on proprietary products, focussing on two therapeutics areas, dermatology and neurology in US market.
The proprietary products division targets unmet patient needs utilising previously approved active ingredients through product improvement opportunities and repurposed drugs.
Dr. Reddy’s has a portfolio of four products in dermatology in the US market with sales of around $36 million in FY15.
The company last week launched ZEMBRACE SymTouch or sumatriptan succinate injection, an innovative drug-device combination product intended for the treatment of acute migraine in adults.
The drug maker is also planning to launch a differentiated topical steroid for psoriasis treatment in the coming weeks.
The company expects the three products to have potential sales of around $50-75 million in the near term.
Shares of Dr. Reddy’s declined 1.73% to close at ₹ 3,050 on BSE on Monday, while the benchmark Sensex fell 0.18% to end at 24,824.83 points.