New Rx, OTC, and generics (June 2010)


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

Key Points


New drugs

Ferndale has launched Pramosone ECream (hydrocortisone acetate 2.5%, pramoxine HCl 1%), for control of itching that accompanies mild-to-moderate atopic dermatitis flares.

FDA has approved Gilead's Cayston (aztreonam for inhalation solution), a treatment of respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. It is expected that Cayston will be available through specialty pharmacies.

Covidien has introduced EXALGO [1] (hydromorphone HCl) Extended-Release Tablets CII, the only extended-release hydromorphone treatment available in the United States. Available in 8-mg, 12-mg, and 16-mg tablets, it provides relief for 24 hours per dose to opioid-tolerant patients with moderate-to-severe chronic pain.

Quinnova has received FDA clearance for Neosalus Cream for the treatment of various dermatoses, including atopic dermatitis and hand eczema.

Galderma announced FDA approval of Differin (adapalene) Lotion 0.1%, the first lotion formulation of the retinoid adapalene, for the treatment of patients aged 12 years and older with acne vulgaris on the face and other areas of the body. The lotion is available in an easy-to-use pump dispenser.

Sirion's Zirgan (ganciclovir ophthalmic gel), approved by FDA in September 2009, is now available for the treatment of acute herpetic keratitis (dendritic ulcers).

New generics

Perrigo, an authorized generic distributor for Ferndale Laboratories, has launched hydrocortisone acetate 2.5% and pramoxine HCl 1% (comparable to Analpram HC Cream). The corticosteroid and topical anesthetic combination is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Teva announced that FDA has granted final approval for its generic versions of two Merck antihypertensive agents: losartan potassium (Cozaar) and losartan potassium and hydrochlorothiazide (Hyzaar).

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