USFDA Archives - indiabusinessview

Vivimed acquires Actavis drug facility for Rs 122 crore, gets US generic entry

August 1, 2013August 20, 2014Editor

Vivimed Labs is acquiring a drug-making facility in India, that comes with regulatory approval from the US Food and Drug Administration (US FDA), giving it acess to the US market. It will get two products as part of the deal and some outsourcing contracts that will give it access to quicker revenue streams. In the longer run, it plans to file to sell new drugs from this facility.

Lupin to sell generic Glumetza in US market, with 6-month sole seller status

July 23, 2013August 20, 2014Editor

Lupin’s U.S. subsidiary, Lupin Pharmaceuticals Inc., has got approval to sell the generic form of an anti-diabetes drug (for type II diabetes) in the U.S. market. Currently, specialty biopharmaceutical company Santarus Inc. holds the right to market the patented drug Glumetza HCL ER in the U.S. market, the generic form of which (Metformin Hydrochloride extended release tablet) Lupin will market in dosages of 500 mg and 1000 mg.

Natco Pharma gets first-to-file on generic Tamiflu

February 9, 2011August 20, 2014Editor

Natco Pharma, an Rs 440 crore turnover pharmaceutical company, has challenged the US patent on Tamiflu held by Gilead Sciences, and licensed to F. Hoffmann-La Roche in 1996. Both Natco and Gilead announced this in separate statements. Natco said that the FDA has accepted its abbreviated new drug application (ANDA) for generic Tamiflu or oseltamivir phosphate.

Aurobindo gets US FDA approval for generic ampicillin

August 19, 2010August 20, 2014Editor

The US Food and Drug Administration (FDA) has approved Aurobindo Pharma Ltd’s application to market generic ampicillin sodium in the US market. The regulator has approved the pharmaceutical company’s application to market the drug in injection form, in six dosage strengths of 10g, 1g, 2g, 125mg, 250mg and 500mg.

Lupin plant clears US FDA hurdle

January 20, 2010August 20, 2014Editor

Lupin’s key manufacturing plant in Mandideep cleared what could have become a hurdle, after it addressed concerns raised earlier by the drug regulator. Earlier, the US drug regulator had issued a warning letter to the company for its cephalosporins facility, asking it to rectify deficiencies or face action. Unlike Ranbaxy Laboratories, Lupin’s drug supplies to the US were not affected.

Sun Pharma receives USFDA approval for ophthalmology product

November 8, 2009August 20, 2014Editor

The USFDA has granted an approval for Sun Pharma to start selling the generic version of Acular, ketorolac tromethamine ophthalmic solution, 0.5%.

Ketorolac tromethamine ophthalmic solution is prescribed to provide temporary relief of ocular itching due to seasonal allergic conjunctivitis, and also in treating post-operative inflammation in patients who have undergone cataract extraction.

Acular, a licensed medication of US-based Allergan, has annual sales of $40 million a year in the US.