Taro And Mylan Gain FDA Approvals

As the New Year started, further drugs were approved by the US Food andDrug Administration, two for Taro Pharmaceuticals - an Israeli-owned company - and one for US firm Mylan Laboratories.

On January 1, Taro received FDA notification that its Abbreviated New Drug Application for clomipramine hydrochloride capsules, 25mg, 50mg and 75mg had been okayed, as had an ANDA for fluocinonide solution USP, 0.05%. The ANDA for Mylan's generic version of the Wyeth-Ayerst-discovered non-steroidal anti-inflammatory Orudis (ketoprofen), in 50mg and 75mg strengths, also gained approval from the FDA.

Taro chairman Barrie Levitt commented: "Taro's substantial R&D program produced impressive results in 1996, with seven ANDA approvals [in the USA] during the year." A company statement also noted that the market for the three strengths of clomipramine HCL was estimated by industry sources at around $48 million, and that of fluocinonide solution at about $4.7 million. Taro says it currently has multiple regulatory filings in Canada and Israel, and 10 ANDAs submitted to the FDA.