Unichem Laboratories announced in May 2019 that it has been granted a tentative ANDA approval from FDA for cetirizine hydrochloride and pseudoephedrine hydrochloride extended-release tablets USP, in the strengths of 5 mg/120 mg. These tablets, indicated for nasal decongestant and antihistamine, are a generic version of Johnson & Johnson’s Zyrtec-D 12 Hour (cetirizine hydrochloride and pseudoephedrine hydrochloride, 5 mg/120 mg) extended tablets. On receipt of final approval, the product will be commercialized from Unichem’s Goa Plant.

FDA has granted final approval of the first generic naloxone hydrochloride nasal spray, manufactured by Teva. This is a generic version of Narcan, a medication that can stop or reverse the effects of an opioid overdose. It was tentatively approved by FDA on 8 June 2018.

Douglas Throckmorton, Deputy Centre Director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement, ‘In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone’.

Narcan has been sold as a nasal spray in the US since 2016. Pharmacists can dispense it without a prescription. It is also available as a generic or branded drug in automatic injectors, pre-filled syringes and vials.

Related article
Teva launches generic tadalafil but delays launch of generic Suboxone

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.