Formulary Watch |

First-time generic approvals December 2010

Generic drugs approved by FDA (through November 2010): Zafirlukast tablets and Desloratadine tablets

Management with specialty pharmaceuticals imminent for various conditions

Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia.

Focus on Azilsartan: A next-generation angiotensin II receptor blocker for the treatment of hypertension

Azilsartan medoxomil (TAK-491), the prodrug form of azilsartan (TAK-536), is an ARB under review for FDA approval for the treatment of hypertension.

Rivaroxaban comparable to warfarin in stroke prevention

Rivaroxaban, an oral direct Factor Xa inhibitor given once daily was superior to warfarin in reducing the risk of stroke and non-central nervous system systemic embolism in patients with AF, with comparable rates of bleeding in the pre-specified on-treatment population, according to results from the ROCKET AF study.

The non-specialty pharmaceutical pipeline: What's on the horizon?

About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."

Dabigatran etexilate (Pradaxa): An oral direct thrombin inhibitor

New molecular entity: Dabigatran etexilate (Pradaxa) was approved for stroke prevention in atrial fibrillation.

Outcomes essential for adopting new­leukemia therapies

The outcomes associated with treating patients with chronic myelogenous leukemia improved dramatically when FDA approved imatinab. Subsequently, newer agents in the same therapeutic class have been approved, and early clinical studies suggest that they may become the new standard of care.

FDA Pipeline Preview, December 2010 (Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502)

Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.

FDA Actions in Brief December 2010 (Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron)

Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron

Ongoing FDA safety review: pioglitazone and potential increased risk of bladder cancer

FDA, in conjunction with Takeda Pharmaceuticals and researchers from the University of Pennsylvania and Kaiser Permanente Northern California, reported 5-year interim results of an ongoing, 10-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer.

Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz): Folate-containing oral contraceptive tablets

New molecular entity: Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz) was approved to treat symptoms of premenstrual dysphoric disorder and moderate acne in women at least 14 years of age, and to supplement folate levels in women wishing to use oral contraception.

Aspirin reduces risk of colorectal cancer incidence, mortality

Aspirin taken for several years and at doses ?75 mg a day was found to result in both a reduced 20-year risk of colorectal cancer incidence and mortality, according to an analysis published ahead-of-print on the Lancet website.

McNeil issues wholesale, retail level recalls

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.

Manufacturer agrees to withdraw propoxyphene from the market

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing products containing propoxyphene from the market as well.

FDA approves denosumab for prevention of SREs in patients with bone metastases from solid tumors

FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.

FDA approves Vyvanse for treating ADHD in teens

FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.

FDA approves onabotulinumtoxinA to prevent chronic migraine

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.

Guidance emerges on specific types of combo therapy for hypertension

With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.

FDA issues complete response letter for lorcaserin

FDA has issued a complete response letter for lorcaserin?s (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese?or patients who are overweight?and have at least 1 weight-related co-morbid condition.

Risk of AF in cancer patients grows with intravenous bisphosphonate therapy

Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation, supraventricular tachycardia, and stroke, according to research published online Oct. 12, 2010 in the Journal of Clinical Oncology, as HealthDay News reported.

Infertility risk rises in women on multiple antiepileptic drugs

For women with epilepsy, the risk of infertility increases with each additional antiepileptic drug, and more than one-third may be unable to conceive, according to research published online Oct. 11, 2010 in Neurology, HealthDay News reported.

HIV drug saquinavir to get new safety data on label

New safety information has been added to the label for the HIV antiviral drug saquinavir mesylate (Invirase, Genentech), describing potentially life-threatening side effects on the heart when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, according to FDA.

New label information to advise that GnRH agonists for prostate cancer could increase risk of diabetes and cardiovascular diseases

FDA is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs? labels.

FDA warns of increased risk of death in patients administered tigecycline compared to other antibiotics

In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections.

FDA approves onabotulinumtoxinA to prevent chronic migraine

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.

FDA OKs duloxetine hydrochloride to treat chronic musculoskeletal pain

FDA has cleared duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, giving patients with such conditions another treatment option.

FDA approves trastuzumab to treat HER2-overexpressing metastatic gastric or gastroesophageal cancer

On October 20, 2010, FDA approved trastuzumab (Herceptin, Genentech) for use in combination with cisplatin and capecitabine or 5-fluorouracil to treat patients with human epidermal growth factor receptor 2-overexpressing metastatic gastric or gastroesophageal junction cancer who have not received prior treatment for metastatic disease.

First IV formulation for acetaminophen approved

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.

FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery

Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

First warfarin replacement approved

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. It is the first replacement for warfarin to win FDA approval. Warfarin was approved in 1954.