Positive news for Pfizer's top-selling drug that could delay competition

US pharma giant Pfizer (NYSE: PFE) received good news today, when the US Food and Drug Administration granted approval for a new formulation of its top-selling drug Lyrica (pregabalin), which in December next year is facing patent expiry.

The US FDA has approved Lyrica extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). However, Lyrica CR did not receive approval for the management of fibromyalgia, which is the drug’s original indication.

If physicians switch patients to the new formulation, this is a regulatory decision that could fend off generic competition a little longer for Lyrica, which last year generated sales of $3.13 billion in the USA alone, a 26% year-on-year rise, but the news had virtually no impact on Pfizer’s shares