New Rx, OTC, and generics (October 2009)


A survey of new Rx, new indications, new generics, and new OTC

Key Points


New drugs

King Pharmaceuticals announced FDA approval of Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules for oral use. Embeda is the first FDA-approved long-acting opioid designed to reduce drug liking and euphoria when tampered with. If the drug is crushed or chewed, naltrexone is released and absorbed with the morphine, reversing the morphine's subjective and analgesic effects. For more information, call 800-776-3637.

Schering-Plough announced FDA approval of Saphris (asenapine) sub-lingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Saphris can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both indications simultaneously. For more information, call 908-298-4000.

New indications

Merck announced the FDA has approved an expanded indication for Isentress. Isentress is used in combination with other antiretroviral (ARV) medicines for the treatment of HIV-1 infection in adult patients. The expanded indication now includes use by treatment-naïve adults (patients starting HIV-1 therapy for the first time), as well as in treatment-experienced adult patients. For more information, visit

UCB and Sanofi-Aventis U.S. have announced FDA approval of Xyzal (levocetirizine) for treating children six months and older for symptoms of perennial allergic rhinitis and chronic idiopathic urticaria, and for children two years of age and older for symptoms of seasonal allergic rhinitis. Until now, Xyzal, a once-daily prescription antihistamine offered in both tablet and liquid formulations, has been used to treat symptoms of indoor and outdoor nasal allergies and chronic idiopathic urticaria in patients 6 and older. For more information, call 888-669-9992.

New generics

Sun Pharmaceuticals announced FDA approvals for two Abbreviated New Drug Applications (ANDAs) for oxaliplatin for injection and sumatriptan tablets. The oxaliplatin injections, 50 mg and 100 mg packed into single-use vials, are therapeutically equivalent to Eloxatin injections from Sanofi-Aventis. The sumatriptan tablets, 25 mg (base), 50 mg (base), and 100 mg (base), are therapeutically equivalent to Imitrex tablets from GlaxoSmithKline. Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received FDA approval for its ANDA for levonorgestrel tablets0.75 mg for over-the-counter use in women 17 years of age and older, as well as for prescription use in women under the age of 17. The product is the generic equivalent of Duramed Pharmaceuticals' Plan B (Rx/OTC), indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. For information, visit

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