In an SEC filing earlier today, Rule Breakers pick Momenta Pharmaceuticals (NASDAQ:MNTA) announced that an FDA review of its lead drug would take longer than expected.

Momenta and partner Novartis (NYSE:NVS) have been awaiting an FDA response on their generic version of Sanofi-Aventis' (NYSE:SNY) Lovenox since August 2005. Previous guidance for when the FDA review would come in was 18 months to 24 months from this submission date, which would have had approval coming this summer.

With the guidance now nearing its end, Momenta is extending the timeline by an indeterminate amount of time "due to a change in the projected timing of certain activities required for the completion of the FDA's review."

Details on these needed activities were not mentioned in the SEC filing, so it's unclear whether the delay amounts to a request for more data on the drug (which could mean years of extra work on it), or some sort of internal FDA delay (which could perhaps cause only months or weeks of delay on the generic drug application).

June hasn't been all bad for Momenta. The complex generics and biosimilar industry received some good news from a bill making its way through Congress. European Union medical authorities also brought good news last week with a positive opinion and upcoming approval of the second generic biologic in the EU, which was a biosimilar developed by Novartis.

Even if you take the worst-case scenario that Momenta's generic Lovenox never gets approved, investors don't seem to be prescribing too much value to the rest of its pipeline, including its in-house blood thinner candidate in a phase 1 study. Trading at an enterprise value of around $245 million, shares of Momenta are a good deal for long-term investors wanting to get a foot in the nascent generic biologics industry.

Momenta Pharmaceuticals is a Rule Breakers selection. You can check out all our recommendations, as well as get access to our message boards and exclusive content, with a 30-day free trial.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.