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TruPharma obtains FDA OK for generic Apokyn

The Food and Drug Administration approved TruPharma’s apomorphine hydrochloride cartridges, the first generic of Apokyn.

TruPharma and its development and commercial partner Sage have received the Food and Drug Administration’s blessing for generic apomorphine hydrochloride cartridges 30 mg/3 mL (10 mg/mL).

The medication is the generic of Apokyn, with Brituswip.US WorldMeds as its licensee and distributor.

[Read more: FDA green-lights Alembic's generic Comtan]

It is used by injection, as needed, to treat loss of control of body movements in people with advanced Parkinson's disease.

Sage is the first approved applicant for apomorphine hydrochloride injection, 30 mg/3 mL (10 mg/mL), single-patient use glass cartridge for use with a reusable pen injector and therefore is eligible for 180 days of Competitive Generic Therapy exclusivity.

[Read More: NACDS, Johns Hopkins Center for Health Security highlight pharmacy’s role in health equity]

TruPharma has commenced commercial marketing of Sage’s generic cartridge product. The company also will continue supplying apomorphine hydrochloride cartridges to the trade, but in limited quantities due to current manufacturing and supply chain constraints. 

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