Busy Season in Pharma

It’s been an active summer for pharmaceutical firms, who’ve been particularly busy adding and removing products from the marketplace and providing fresh information to professional users. Here’s a roundup of vital information that has emerged.

Market Withdrawals

Because of an increased risk of death associated with aprotinin injection (Trasylol) compared with either aminocaproic acid or tranexamic acid, Bayer Pharmaceuticals has removed all remaining stocks of the agent from the U.S. market. Subsequent access to aprotinin injection will be limited to investigational use based on a special treatment protocol. For more information on this, call (888) 842-2937.

Meanwhile, nedocromil sodium inhalation aerosol (Tilade) has been discontinued. Once current supplies are depleted from pharmacies, it no longer will be available. A number of factors led to the decision, including the inability to find a qualified manufacturer of the chlorofluorocarbon propellant.

GENERICS

  • Calcipotriene 0.005%/betamethasone dipropionate 0.064% Topical suspension (generic Taclonex) for scalp psoriasis;
  • Drospirenone/ethinyl estradiol tablets (generic Yasmin) oral contraceptive;
  • Paroxetine CR 12.5 and 25 mg tablets (generic Paxil CR). Mylan has 180 days of marketing exclusivity;
  • Ropinirole tablets (generic Requip);
  • Zaleplon capsules (generic Sonata).

New Approvals

Certolizumab pegol (Cimzia) injection has been approved by the Food and Drug Administration (FDA) to treat adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. It is a pegylated tumor necrosis factor antagonist. The most common side effects are headache, upper respiratory infections, abdominal pain, injection site reactions, and nausea. It is dosed as an initial 400 mg SC injection followed by 400 mg SC injections at weeks two and our.

A maintenance regimen of 400 mg subcutaneous every four weeks is recommended for patients who obtain a clinical response after the initial three injections. The drug is available as a package that includes everything required to reconstitute and inject the drug (also two vials of drug, each with 200 mg Cimzia). Patients need to be evaluated for increased infection risk and opportunistic infections. Patients should be screened for tuberculosis prior to commencing therapy.

Desvenlafaxine 50 mg tablets (Pristiq), a serotonin-norepinephrine reuptake inhibitor (SNRI), have been FDA approved for the treatment of adults with major depressive disorder. It is dosed once daily. To reach the therapeutic dose, titration is unnecessary. Dose adjustments are necessary for severe renal impairment or end-stage renal disease patients, where the dose should be adjusted to 50 mg every other day. Nausea, dizziness, hyperhidrosis, constipation, and decreased appetite are the most common side effects.

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