Wockhardt received approval from the US Food and Drug Administration (USFDA) for Zaynich (WCK 5222), an intravenous antibiotic indicated for the treatment of complicated urinary tract infections (cUTIs).
The drug had earlier been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the USFDA.Wockhardt has previously indicated that Zaynich has the potential to generate annual sales of $1 billion to $2 billion globally, with nearly 40% of revenue expected from the US market.
The antibiotic also secured approval from India’s drug regulator, CDSCO, last week, with the company estimating a domestic revenue opportunity of around ₹150 crore. Zaynich is currently under review by the European Medicines Agency (EMA).
Lupin
Lupin has received USFDA approval for its generic version of Sutab, a prescription medicine used for bowel preparation before colonoscopy procedures.
The company is the first applicant to file for the generic version and has been granted 180 days of marketing exclusivity in the US market. The reference drug has annual sales of approximately $132.8 million.
Zydus LifesciencesZydus Lifesciences has announced that its ₹1,100 crore share buyback will open on June 4 and close on June 10.
The company has revised the buyback size to 87.3 lakh shares and increased the buyback price to ₹1,260 per share from ₹1,150 earlier. Under the offer, small shareholders will be entitled to tender five shares for every 49 shares held as of the record date.
The record date for the buyback was May 29, making shareholders who held shares in their demat accounts as of May 28 eligible to participate. As of March 31, the company had more than four lakh small retail shareholders holding a combined 4.8% stake.
Shilpa Medicare
Shilpa Medicare informed exchanges that the USFDA conducted a pre-approval inspection at its Unit VI facility in Dabaspet, Bengaluru, between May 25 and May 29.
The inspection concluded with the issuance of Form 483 carrying five procedural observations. The company said none of the observations were repeat findings or related to data integrity concerns.
The facility manufactures specialised dosage forms, including oral dissolving films and transdermal patches.
It currently holds a Voluntary Action Indicated (VAI) status from the USFDA and is also approved by global regulators including the EMA, UK’s MHRA, Saudi Arabia’s SFDA and Australia’s TGA.
Shilpa Medicare said it will submit its response within the prescribed timeline and does not expect the observations to have any material impact on business operations or product supplies from the facility.
