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FDA Busy Approving Dozens Of New Drugs

PITTSBURGH (KDKA) - Every year, the FDA carefully reviews tons of new prescription drugs, green-lighting some and canning others.

It all boils down to making sure the right medicines are available to help treat whatever ails you.

Recently, the FDA has been busy approving new drugs, which could mean more options for you.

In 2015, 45 new medicines were approved, which is a two-decade high.

In recent years, new approvals tended to be for drugs similar to existing choices - sometimes called "me-too" drugs.

But, the last year brought new types and classes of medication from cancer drugs to medicines for congestive heart failure to treatments for rare diseases to vaccines.

For example, the statins were the mainstay of lowering cholesterol.

"There is a new option now for cholesterol. It is an injectable that you do every two weeks call Praluent," AHN Pharmacist Paul Higginbotham said. "For people with hard to control cholesterol, it's showing a 36 to 59 percent reduction in bad cholesterol, or LDL."

Another new one is Praxbind, which was developed to counter potential problems with the relatively new blood thinner -- Pradaxa.

"Up until recently there have been no reversal agents for that drug. So, that one is very exciting," Higginbotham said.

Hepatitis C has been treated with years of interferon injections to boost the immune system in combination with antivirals.

But, adding 12 weeks of a new drug called Daklinza can actually fight the virus in a lasting way.

"To find a drug that could potentially cure hepatitis instead of just abating the symptoms or slowing the progression, is a very exciting thing," Higginbotham said.

Another new one is orkambi, a drug for cystic fibrosis that costs $260,000 a year.

An injectable double chin reducer was also approved.

"Unfortunately, you're going to see with those types of specialty meds, you're going to see a high-price sticker associated with a lot of them because of the high research and development that goes along with those," Higginbotham said. "A lot of times they're not covered initially on the patient's prescription plan, and there is a lot of paperwork and steps involved in getting those medications covered."

In all, 27 of these new drugs were fast-tracked. In other words, they were developed and approved more quickly than usual to get them on the market.

Now comes what's called "post-market surveillance" to see how well they perform and if any problems surface when they're used by more people.

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