FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose Posted 21/06/2019

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first generic naloxone hydrochloride nasal spray, manufactured by Teva Pharmaceuticals (Teva).

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.

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