Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers December 16, 2018
Pharmacy Choice - Pharmaceutical News - Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it [Syrian Arab News Agency] - December 16, 2018

Pharmacy News Article

 9/18/18 - Sun wins approval of glaucoma drug and its once-troubled Halol plant to produce it [Syrian Arab News Agency]

Indias 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 Suns 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.

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 Suns 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 didnt keep the company from winning todays approval.



(c) International 2006-2018, SANA Provided by SyndiGate Media Inc. (Syndigate.info).

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Dec 17: Obesity Management: Overview of Pharmacotherapy
Dec 18: Management of Insomnia and Anxiety Disorders
Dec 19: Efficacy vs. Safety: Treating BPH & Incontinence in the Elderly
Dec 20: Adult Immunizations: A Guide for Pharmacists, Techs & NPs
Dec 27: Medical Marijuana: The Basic and Clinical Pharmacology, Not The Politics
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2018 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415