Teva Pharma launches generic Lovenox & Zyvox in US markets

Teva Pharmaceutical Industries, a leading global pharmaceutical company, announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin s injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT.

Lovenox had annual sales of approximately $1.8 billion in the United States, according to IMS data as of November 2014. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of enoxaparin sodium injection, USP.

Teva has also recently launched the generic equivalent to Zyvox (linezolid) injection which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox injection had annual sales of approximately $464 million in the United States, according to IMS data as of October 2014.

“Teva is committed and focused on building a stronger generic injectable business globally,” said Siggi Olafsson, president and chief executive officer, of Teva Global Generic Medicines. “With the launch of enoxaparin sodium injection, USP and Linezolid injection, accompanied by the reintroduction of three generic injectable products, we are leveraging the strength of our internal and external resources to deliver the right portfolio as part of our growth strategy. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic.”

Teva continues to invigorate the injectable business in the United States with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Additionally, Teva has progressed in building its research and development capabilities in complex, generic injectables including drug-device combinations, complex drug delivery, and complex molecules. This month, Teva has launched Nafcillin for injection, USP and is reintroducing into the market Leucovorin calcium for injection (100 mg/vial), methylprednisolone acetate injectable suspension, USP (40 mg/mL), and ondansetron injection, USP (2 mg/mL).

As of January 22, 2015, Teva had 120 product registrations pending FDA approval, including 29 tentative approvals. Collectively, these 120 products had US sales in 2014 exceeding $86 billion. Of these applications, 87 were “Paragraph IV” applications challenging patents of branded products; 42 of these pending ANDAs are potential first-to-file opportunities.

Hospira recalls seven lots of Propofol injectable emulsion

Hospira, Inc., one of the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, has announced the nationwide recall of seven lots of Propofol injectable emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.

In general, injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. The lot numbers affected by the recall are: Propofol injectable emulsion, 1%, 200 mg / 20 mL (10 mg/mL).

On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence