AUROBINDO PHARMA GETS USFDA NOD FOR HIV DRUG

Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture abacavir sulfate and lamivudine tablets, used in the treatment of HIV

New Delhi, Mar 30 : Aurobindo Pharmatoday said it has received final approval from the US health regulator to manufacture abacavir sulfate andlamivudine tablets, used in the treatment ofHIV.

"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture abacavir sulfate and lamivudine tablets, 600 mg/ 300 mg,"Aurobindo Pharma said in a BSE filing.

The company said the product is being launched immediately.

The approved product is AB rated generic equivalent of VIIV Healthcare Company'sEpzicom tablet. It has an estimated market size of USD 388 million for the 12 months ended December 2016, Aurobindo Pharma said, citing market research reports.

This is the 108th ANDA (including 20 tentative approvals) approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.

Aurobindo now has a total of 314 ANDA approvals (276 Final approvals including 16 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA.

The stock of Aurobindo Pharma was trading 0.98 per cent higher at Rs 678 on the BSE. SVK JM

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BIOGEN WINS TECFIDERA U.S. PATENT DISPUTE WITH FORWARD PHARMA

The companies had been locked in a dispute over patents for dimethyl fumarate, the key active ingredient in Tecfidera, the leading oral MS treatment with sales of about $4 billion in 2016.

A U.S. patent board on Friday ruled against Danish drugmaker ForwardPharma A/S, finding Biogen's patents on its blockbuster multiple sclerosis drug Tecfidera to be valid.

The ruling by the U.S. Patent Trial and Appeal Board (PTAP) frees Bigoen Inc from future royalty payments to Forward and sent the Danish firm's shares down nearly 20 percent. Biogen shares were up 1.4 percent.

The companies had been locked in a dispute over patents for dimethyl fumarate, the key active ingredient in Tecfidera, the leading oral MS treatment with sales of about $4 billion in 2016.

The PTAP ruling found Forward's written patent description to be insufficient to declare infringement by Biogen.

Had Biogen lost it would have had to pay Forward a 10 percent royalty on Tecfidera sales starting in 2021.

Biogen's Tecfidera exclusivity is secured through 2028 under the ruling.

Biogen in January had taken out something of an insurance policy against a potential defeat in the patent dispute. It agreed to pay Forward $1.25 billion to license the company's patents covering multiple sclerosis drugs, giving Biogen a share of Forward's intellectual property. (Reporting by Bill Berkrot; Editing by Tom Brown)

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AUROBINDO HAS EARNED HIGHEST NUMBER OF ANDA APPROVALS IN JANUARY-2016 TO DECEMBER-2016

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