GSK May Face Sooner-than-Expected Generic Competition

GSK May Face Sooner-than-Expected Generic Competition

Draft guidance has newly been issued by the US Food and Drug Administration in a stumbling block to GlaxoSmithKline GSK -0.08%.

A report has unveiled that the draft is a hint that generic competition could be faced by the drugmaker for its Advair medication sooner than some people's expectation.

The medication meant for patients of chronic obstructive pulmonary disorder and asthma is second best-selling in the market. More than $7.8 billion was collected by its sales the previous year. But, patent protection is to end in 2016.

It is being said that generics could presently, easily win the approval of FDA on the basis of bioequivalence. Thereby, they jumped into a multi-billion-dollar market merely in a couple of years. And this was the only issue.

Though, there have been implications, it is not certain when a regulatory approval would be won by a completely substitutable generic version in the US. The reason being Advair was a multifaceted blend of a drug and a mechanism called a diskus.

"The vast majority of analysts have assumed that `true' generic versions of Advair would not likely launch in the U. S. This new draft guidance document suggests otherwise", said analyst Tim Anderson from Sanford C. Bernstein & Co.


FrenchTribune Specials

Cosmic rays does not cause birth defects

According to a new study, cosmic radiations that reach Earth are not strong enough to cause any birth defects.

The study shows that major solar events that send radiation toward Earth do not cause birth defects. The study found that the amount of damaging solar radiation reaching the planet is not enough to cause concern. The researchers...

Most Popular

Crew working to save whale stuck in lagoon on Great Barrier Reef

Wildlife experts and crew members are working to save...

SKA Pathfinder discovers galaxy five billion light years away

A high-tech radio telescope, SKA Pathfinder telescope in...

Leakage leads to Immediate Landing Of NASA’s Massive Balloon

NASA's massive heavy-lift balloon which took off from...

Chile's Calbuco Volcano Eruption Causes Massive Economic Damage

Chile's Calbuco volcano eruption has not only caused...

Poll

Can Greece Come out of Economic Problems: