What do we know about syros pharma?
Syros Pharmaceuticals Pvt Ltd (SPSL) has received approval from the FDA to market a new opioid drug.
The company is the first pharma company to get approval from US regulators for a new generic version of an opioid, according to a statement from Syros.
The FDA has also approved the drug for the treatment of chronic pain.
Syros Pharmaceutical has not yet filed for an application with the US Food and Drug Administration (FDA).
Its first drug, OxyContin, was approved in August 2016 for the acute pain treatment of multiple sclerosis (MS).
“We have received FDA approval for our second opioid drug, the OxyContin® OxyContin NRT-6,” Syros Chief Executive Officer and President, Sanjeev Gopalan, said in a statement.
“We have been working closely with FDA and the FDA Office of Generic Drugs, the lead agency in approving new opioids for patients, to develop and launch this new drug.”
Syros is the only generic version approved by the FDA.
The other two approved opioids, OxyKlonopin (an injectable painkiller) and OxyNaloxone (a nasal spray), have both been approved for the chronic pain treatment.
The US Food & Drug Administration, or FDA, has been monitoring Syros’ application since it was filed in October 2016.
The agency has been reviewing other applications from other companies to try to find out if Syros has a product that has a high likelihood of being approved by FDA.
The FDA has approved OxyContin for the use of opioid painkillers.
But as the drug is already in the market, there is a potential for a second drug to be approved for its use.
The new opioid is a brand-name version of the brand name OxyContin.
It has an estimated street value of $1.4 billion and an estimated wholesale value of more than $30 billion.
In October, Syros filed for a license from the US Pharmacopeia to produce a generic version.
It is a step towards getting a second opioid approved.
“With the FDA approval, we are able to move forward with the production of our second version of OxyContin,” Syro CEO Gopal said.
“Our primary focus now is to bring OxyContin to the marketplace as soon as possible.
We have no plans to delay OxyContin production.”
The FDA approval means Syros is allowed to produce OxyContin generic versions of the painkiller.
The US Pharmacopoeia is the primary regulatory authority in the US for the pharmaceutical industry.
Syms drugs are also in the pipeline for the generic version, as well as the painkillers, but Syros will have to obtain regulatory approval from all the states and territories before Syros can start selling them.
Syros will also be able to sell OxyContin at generic price to individuals and entities in the states it is in.
Syros also plans to distribute OxyContin directly to the retail pharmacy.