Ranbaxy receives tentative drug approval from USFDA
The US Food and Drug Administration (USFDA) has granted a tentative approval to Ranbaxy Laboratories Ltd for the manufacturing and marketing of its drug Nexium, popularly prescribed in the treatment of heartburn.
Announcing this here to the Bombay Stock Exchange (BSE) on Thursday, an official statement issued by Ranbaxy Laboratories said that the USFDA has granted approval on Nexium with Esomeprazole 20 mg (base) and 40 mg (base). Nexium is the registered trademark of Astra Zeneca.
According to the pharmaceutical marketing research major Intercontinental Market Services (IMS), in December 2007 Esomeprazole became the second largest selling drug in the US with total annual market sales touching $5.5 billion.
According to the statement, Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity.
Esomeprazole is indicated for short-term treatment of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD.)
The manufacturing and marketing would be done by Jacksonville (Florida) based Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
Enter your email to get our daily newsletter in your inbox
- In an interaction with members of the Indian Women’s Press Corps (IWPC), Sitharaman said that consumer sentiment about the tax burden on auto fuel was understandable.
- Nearly 1.1 million vaccine doses were administered to people above the age of 60 and those in the 45-59 age group till Thursday.
- Mohapatra said the idea came during Modi’s meeting with Marriott International president and chief executive Arne Sorenson, who complained about the complex regulations in starting and running a hotel in India.
- ICICI Bank’s move comes days after rival lenders such as State Bank of India (SBI), Kotak Mahindra Bank and Housing Development Finance Corp. Ltd cut their home loan rates.
- These votes will have to be disclosed to unit holders under existing regulations. Voting will be at the MF level (rather than scheme level).
- Supply of vehicles from Maruti Suzuki India Ltd—as part of the alliance with Suzuki Motor Corp—has helped Toyota increase its domestic market share in the premium hatchback and entry-level SUV segment, where it was not present before.
- The top three states by GVA were Maharashtra, Gujarat, and Tamil Nadu. They had a share of 41% in the total GVA. Rural India added nearly as much GVA (49%) as urban India (51%).
- Using average consumption shares to calculate the burden of an indirect tax has a problem.
- Retail buyers continued to purchase gold in India as prices declined to a near one-year low.