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New drugs

In January, Nupathe Inc. won U.S. approval to sell the first skin patch to treat migraines. The treatment, called Zecuity, delivers sumatriptan, the most-prescribed migraine headache medication, through a mild electrical current. The company expects to have the product available for sale in the fourth quarter of this year. Migraine is a neurological disorder that affects about 31 million adults in the United States. It causes patients to suffer from nausea and vomiting, as well as headache pain. A company spokesman indicated that the price will be comparable to the $95 cost of a similar injectable medication. (www.zecuity.com)

In January, FDA approved Flublok from Protein Sciences Corp. for people 18-49 years old, making it the first recombinant vaccine for the prevention of seasonal influenza available on the market. Approval for all individuals 18 years and above is expected later in 2013. Flublok is the first influenza vaccine to be made in a 100% egg-free system and without the use of live influenza virus. Highly purified, it has no preservatives (thimerosal), antibiotics or adjuvants, and contains three times the active ingredient in traditional i

nfluenza vaccines. Flublok will be widely available for the 2013-2014 influenza season and is available in limited supply for the current season. (www.flublok.com)

Santarus, Inc. announced in January that FDA has approved Uceris (budesonide) Extended-Release Tablets for the induction of remission in patients with active, mild-to-moderate ulcerative colitis (UC). The company expects to launch the product in March. As many as 700,000 people in the United States may suffer from UC, a form of chronic inflammatory bowel disease that produces inflammation and ulcers along the inside of the colon. UC is characterized by periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. While symptoms may resolve without treatment, the disease usually requires medication to go into remission. Dosing regimen for adult patients is one 9-mg tablet taken orally once daily, in the morning, for up to 8 weeks. Patients should not eat grapefruit or drink grapefruit juice while taking Uceris (www.santarus.com)

Pfizer Inc. announced in January that Quillivant XR (methylphenidate hydrochloride) CII for extended-release oral suspension is now available in the United States for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate treatment for ADHD. FDA approved the product in late September, 2012, for the treatment of ADHD in patients 6 years old and above. Pfizer plans to offer the product to patients in need through its Pfizer Helpful Answers program, which helps eligible patients in the U.S. in need get access to their Pfizer medications. (866-706-2400 / www.PHAHelps.com)

New generics

Early in January, Dr. Reddy’s Laboratories announced the launch of its generic 1-mg finasteride tablets, used for treating male pattern hair loss, in the U.S. mark

et. The tablets are bioequivalent generic version of Merck Sharp & Dohme’s Propecia tablets, it added. The generic 1-mg ginasteride tablets are available in bottle counts of 30 and 90, it added. FDA granted the product 180 days of marketing exclusivity. (www.drreddys.com)

Also in January, FDA gave marketing approval to Lupin Pharmaceuticals’ levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg, its seventh oral contrace

ptive to win FDA approval. The tablets are the generic equivalent to Watson Laboratories’ Lutera 28 tablets, indicated to prevent pregnancy in women. Lupin is expected to begin to market the product soon. (lupinpharmaceuticals.com)

FDA has approved Mylan Pharmaceuticals’ abbreviated new drug applications (ANDA) for rizatriptan benzoate tablets, 5 mg (base) and 10 mg (base), and rizatriptan benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), the generic equivalents to Merck’s Maxalt tablets and Maxalt MLT tablets,respectively, and granted Mylan marketing exclusivity for 180 days for the orally disintegrating product. The generic products are indicated as migraine therapy for adults with or without aura. Shipment of both products has begun. (www.mylan.com)

Late in December, Mylan received final FDA approval for its ANDA for phenytoin chewable tablets USP, 50 mg., the generic version of Pfizer’s Dilantin Chewable Tablets, indicated for control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures connected with neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments. This product is shipping now. (www.mylan.com)

Also in December, FDA gave final approval to Mylan’s ANDA for candesartan cilexetil and hydrochlorothiazide tablets, 16/12.5 mg, 32/12.5 mg, and 32/25 mg. The product is the generic version of AstraZeneca’s Atacand HCT and is indicated for the treatment of hypertension. This fixed-dose combination is not indicated for initial therapy. Mylan was granted 180 days of generic drug marketing exclusivity for this product strength. All approved strengths of this product are shipping immediately. (www.mylan.com)

ACETO Corporation announced in December that Rising Pharmaceuticals Inc., its finished dosage form generics subsidiary, has launched the first generic version of the 500-mg strength (microsize) of griseofulvin tablets USP, an FDA approved generic version of Valeant Pharmaceutical’s Grifulvin V. The launch of the 500-mg strength of griseofulvin tablets USP follows the previously announced launch of the first generic version of the 125-mg and 250-mg strengths of Ultramicrosize Griseofulvin tablets USP by Rising Pharmaceuticals in November 2012. (www.mylan.com)

OTC

Late in January, FDA approved Merck’s Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination. The condition affects an estimated 33 million Americans, most of them older women. Oxytrol is an anticholinergic and contains oxybutynin to help relax the bladder muscle. It is the first OTC drug in this class for treatment of overactive bladder. The product comes in a patch that is applied to the skin every four days and delivers 3.9 mg of oxybutynin per day. Oxytrol will remain available for men with overactive bladder by prescription only. (www.OxytrolForWomen.com)

Vitalah, creator of Oxylent [1], has released an effervescent version of its adult formula that is free of additives, preservatives, colors, gluten, dairy, caffeine, sugar, and calories. Its micronutrient blend includes enzymes, electrolytes, amino acids, antioxidants, vitamins, and minerals delivered in a fast-absorbing, stevia-sweetened powder that is added to water and drunk.  Product is available in a 30-count and convenient 7-count travel size. (www.oxylent.com)

 

NEW DEVICE

 Sanofi’s Auvi-Q [2] (epinephrine injection, USP) is now available by prescription in U.S. retail pharmacies nationwide. Auvi-Q is the first and only epinephrine auto-i

njector that provides audio and visual cues for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. The size and shape of a credit card and the thickness of a smart phone, Auvi-Q talks patients and caregivers step-by-step through the injection process.

Auvi-Q

is available in two different dosages. The 0.3-mg epinephrine injection is intended for patients who weigh 66 pounds or more. The 0.15-mg epinephrine injection is intended for patients who weigh 33 to 66 pounds. Each pack contains two devices, each containing one dose of epinephrine, and a nonactive training device. (https://www.auvi-q.com/)  

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