Orphan drug designation is given by USFDA for rare diseases that affect less than 200,000 patients in the USA. Since the market for drugs intended to treat rare diseases is small, USFDA extends special incentives to companies involved in the discovery and development of such drugs. These incentives include a seven year marketing exclusivity, specific tax credits and waiver of prescription drug user fees (which is about $ 1.5 million per indication). Special grants and benefits to defray the costs of clinical research on these drugs may also be extended by USFDA. These drugs may be eligible for a fast track approval process facilitating early market launch.

NATCO is close to completing the Phase I clinical trial of NRC-AN-019 in India. NATCO has plans to take the drug forward for further clinical trials in USA and other countries, in addition to India.

Source: Press Release

In response to a U.S. Food and Drug Administration press release today announcing warning letters and Import Alert for Drugs issued to Ranbaxy Laboratories Ltd regarding drug products produced in two Ranbaxy plants in India, the company issued the following statement:

“Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA’s testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy’s drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”

According to the FDA announcement, the warning letters and Import Alert do not apply to Ranbaxy’s other facilities including its three manufacturing facilities in the U.S., Ohm’s Laboratories facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the U.S. healthcare system, including:  Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.