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A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling
americanpharmaceuticalreview
April 07, 2021
Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members.
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FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief
americanpharmaceuticalreview
March 29, 2021
The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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FDA Authorizes Cue Health's COVID-19 Test for At-Home, OTC Use
americanpharmaceuticalreview
March 12, 2021
Cue Health has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) sale of its fast, accurate, COVID-19 test, making it the nation's first molecular diagnostic test available to ...
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Takeda concludes sale of select OTC and non-core assets to Hypera Pharma
expresspharma
February 01, 2021
Takeda Pharmaceutical Company announced the completion of its previously-announced sale of a portfolio of select products sold in Latin America to Hypera S.A. for a total value of $825 million. This divestment agreement was first announced in March 2020.
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FDA Releases Update on OTC Monograph Drug User Fee Program Implementation
americanpharmaceuticalreview
January 20, 2021
The CARES Act, enacted in March 2020, amended the Federal Food, Drug, and Cosmetic Act to provide FDA authority to assess and collect annual facility fees from owners of qualifying OTC monograph drug facilities (in addition to fees for OTC monograph ...
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FDA Authorizes Antigen Test as First OTC At-Home COVID-19 Diagnostic Test
americanpharmaceuticalreview
December 17, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.
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Takeda sells select products to Celltrion in Asia Pacific
pharmaceutical-technology
December 02, 2020
Takeda Pharmaceutical Company has completed the previously announced sale of a portfolio of select products to South Korean biopharma firm Celltrion for $278m, including milestone payments.
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Dr Reddy’s relaunch OTC Famotidine Tablets USP, 10 mg and 20 mg, in US
expresspharma
October 22, 2020
They are acid reducers that prevent and relieve heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.
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OPPI, FICCI, IPA come together to highlight need for OTC regulations in India
expresspharma
October 09, 2020
Organise a webinar where experts emphasise the importance of a well-regulated OTC framework to empower patients towards responsible self-medication.
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Dr Reddy’s launches OTC Olopatadine Hydrochloride Ophthalmic Solution in US
expresspharma
September 18, 2020
They are indicated for the temporary relief of eye allergies like itchy eyes due to pollen, ragweed, grass, animal hair and dander.