FDA approves first generic version of Lovenox

Sanofi-aventis has reservations about Sandoz drug for treating DVT

The US Food and Drug Administration (FDA) has approved the first generic version of Lovenox (enoxaparin sodium injection), developed by Sandoz, the generics division of Swiss pharmaceutical firm Novartis, in collaboration with US-based biotechnology firm Momenta Pharmaceuticals.

However, French drugmaker Sanofi-aventis, the manufacturer of the reference product that has been available in the US since 1993, has expressed reservations about the approval.

Sanofi-aventis says it is concerned about potential implications for patient safety, claiming that the product has not been subjected to the same extensive clinical trials to demonstrate its efficacy and safety as was done with its product.

The firm could also see the launch of the generic product have an impact on its sales in the US.

Sanofi-aventis had US sales of US$2.7bn in 2009 for the reference product, which has been used to treat an estimated 200 million patients worldwide since it was launched in 1993 and is the best-selling hospital medicine in the US.

Sandoz claims it provided the FDA with ‘substantial data that demonstrated the equivalence of the Sandoz generic to Lovenox, and addressed potential immunogenicity issues’.

Keith Webber, deputy director of the FDA’s Office of Pharmaceutical Science, said: ‘Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product.’

Prior to the approval, the FDA said it had received a citizen petition questioning the approval criteria for generic enoxaparin sodium injection, but after reviewing the petition ‘determined that current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection’.

Jeff George, global head of Sandoz, said: ‘We welcome the FDA decision to approve our enoxaparin application, and are now looking forward to significantly increasing access to this vital medicine by providing a high-quality, more affordable version.’

He added that with the generic version of Lovenox the firm was delivering on its strategy of being first-to-market with key products.

Product shipment began immediately after the approval was received.

The Sandoz/Momenta Pharmaceuticals product, called M-Enoxaparin, is indicated for use in prophylaxis and for treatment of DVT, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, and the treatment of acute ST-segment elevation myocardial infarction [STEMI].

‘The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased,’ said Craig Wheeler, president and ceo of Momenta.

The product has been approved in the following strengths: 30mg/0.3mL, 40mg/0.4mL, 60mg/0.6 mL, 80mg/0.8mL, 100mg/mL, 120mg/0.8mL, and 150mg/mL.

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