India’s Sun Pharmaceuticals, which is working hard to shift its focus from generic to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma. The drug will be made at Sun’s once-troubled Halol plant, indicating that problems there have been resolved after nearly four years.
Sun said today that the FDA greenlighted the company's SPARC biotech unit for Xelprostm (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated pressure in they eyes of patients with open-angle glaucoma or ocular hypertension. Sun in-licensed the drug from SPARC in 2015.
The drug is novel as the first and only form of latanoprost not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations.
“As the only BAK-free version of latanoprost, XELPROSTM will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” Abhay Gandhi, CEO of Sun North America, said in a statement.
The approval comes a month after Sun won approval of Cequa, a drug for dry eye disease.
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The drugmaker said Xelprostm will be made at Halol, where Sun has been dealing with issues for some time. The FDA issued a Form 483 in 2014 and a warning letter in 2015 for the API plant. Those regulatory setbacks kept it from winning any new drug approvals from the facility, hurting Sun’s growth.
In fact, problems with Halol led the FDA to revoke approval in 2015 of a new epilepsy drug developed by SPARC for Sun after initially giving it an OK. It issued a second complete response letter for the treatment in 2017, again citing the plant problems.
But in June of this year, Sun reported that the FDA had issued an Establishment Inspection Report, indicating issues noted in a February inspection had been cleared. An August pre-approval inspection led to six more observations, which the company said it is addressing, but it didn’t keep the company from winning today’s approval.