Roxane gets first generic equivalent to Voltaren on June 23; ANDA/AADA June wrap-up.

ROXANE GAINS FIRST GENERIC VOLTAREN ANDA APPROVAL on June 29 from FDA ("The Pink Sheet" July 3, T&G-13). The first off-patent version of Ciba-Geigy's nonsteroidal anti-inflammatory drug Voltaren will be available in 25 mg and 50 mg tablets.

Brandname sales of diclofenac sodium are more than $270 mil. annually, FDA's Office of Generic Drugs said in its monthly report on generic drug approvals. Ciba also has a 50 mg diclofenac potassium tablet on the market, Cataflam, which is an immediate-release formulation.

OGD approved 18 ANDAs and three AADAs during the month of June. Because some applications are for more than one dosage strength, OGD noted that it approved the equivalent of 30 applications.

Among the ANDAs approved was Rosemont Pharmaceutical partner LEK Pharmaceutical of the Republic of Slovenia. An ANDA for cimetidine 200 mg, 300 mg and 400 mg tablets was approved by FDA on June 29. Denver-based Rosemont said it will introduce the tablets under its own name "in the coming weeks."

Additionally, one application was tentatively approved, Mova's captopril tablets on June 7; Mova's ANDA is equivalent to four. Therefore, the 22 overall approval actions were equivalent to 34, OGD said. The June numbers are the second highest in 1995, after April's total of 34 (equivalent to 38). The April numbers were the highest since before the generic drug scandal, OGD said at the time ("The Pink Sheet" May 8, T&G-16).