New products for pharmacists: Rx, generic, and OTC (October 20211)


A survey of new Rx, new generic, and new OTC products

Key Points


New drugs

FDA has approved Gilead Science's Complera (200 mg emtricitabine/25 mg rilpivirine/300 mg tenofovir disoproxil fumarate), a single-tablet regimen for the treatment of HIV-1 infection in treatment-naive adults. ( / 800-445-3235)

Fera Pharmaceuticals has launched 4 ophthalmic ointments: Neo-Polycin (neomycin and polymyxin B sulfates and bacitracin zinc) and Polycin (bacitracin zinc and polymyxin B sulfates), indicated for the treatment of susceptible infections of the conjunctiva and cornea, and Neo-Polycin HC (neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone acetate), and neomycin and polymyxin B sulfates with dexamethasone, indicated for the treatment of steroid-responsive inflammatory ocular infections. ( / 414-434-6604)

FDA has approved 2 new strengths for 3-month administration of Abbott's Lupron Depot-PED (11.25-mg and 30-mg leuprolide acetate for depot suspension) to help arrest pubertal development in children with central precocious puberty. (

FDA has approved Janssen's Nucynta ER (tapentadol extended-release tablets in 50-mg, 100-mg, 150-mg, 200-mg, and 250-mg strengths), a centrally acting synthetic analgesic for the management of moderate-to-severe chronic pain in adults and a C-II controlled substance. ( /800-526-7736)

Pernix Therapeutics and ParaPRO have made available prescription Natroba (0.9% spinosad topical suspension) for the treatment of head lice in patients ≥4 years of age. ( / 855-628-7622)

Baxter's Gammagard Liquid (immune globulin infusion [human]) has received FDA approval for subcutaneous administration, enabling patients to self-administer the therapy at home. ( / 866-424-6724)

MedImmune has begun shipping FluMist (influenza vaccine live, intranasal), indicated for eligible patients 2 to 49 years of age, to vaccine distributors serving U.S. healthcare providers. ( / 877-633-4411)

FDA has approved Graceway's Zyclara (imiquimod) Cream 2.5% for the treatment of actinic keratosis on the face or balding scalp. Zyclara is already available in a 3.75% strength formulation. ( / 800-328-0255)

Skinvisible Pharmaceuticals Inc. announced that its licensee, Women's Choice Pharmaceuticals LLC, has launched ProCort, a topical treatment for hemorrhoids. ProCort is a combination of hydrocortisone acetate and pramoxine hydrochloride. (e-mail: / 702-433-7154)

Upsher-Smith has launched Trianex 0.05% (triamcinolone acetonide ointment in 17-g and 85-g tubes) for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Trianex is preservative-free. ( / 800-654-2299)

FDA approved Daiichi Sankyo's supplemental New Drug Application for Welchol (colesevelam HCl) for Oral Suspension to be mixed with fruit juice or diet soft drinks for use as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary hypercholesterolemia, and for use by type 2 diabetics in combination with metformin, sulfonylureas, or insulin. ( / 877-437-7763)

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